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infusionpump
Company:Hospira Inc. Date of Enforcement Report 10/26/12 Class l: PRODUCT Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16027-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes,...
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Company:I-Flow Corporation Date of Enforcement Report 8/31/12 Class l: PRODUCT ON-Q Pump with ONDEMAND Bolus Button. The I-Flow ON-Q pump with ONDEMAND bolus button was manufactured from October 18, 2002 through April 30, 2012 and distributed from May 3, 2010 through May 1, 2012 Use: The On-Q pump with ONDEMAND bolus button is used for...
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Company: Smiths Medical ASD, Inc. Date of Enforcement Report 8/2/12 Date Recall Initiated: February 14, 2012 Class l: PRODUCT Smiths Medical Medfusion 4000 Syringe Infusion Pump.The Medfusion 4000 is a wireless, electronic infusion pump used to provide intravenous (IV) infusions of fluids, medications, blood, and blood products to adult, pediatric, and neonatal patients.Z-2107-2012 Distribution Dates:...
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Company: CareFusion 303, Inc. Date of Enforcement Report 8/1/12 Date Recall Initiated: May 25, 2012 Class l: PRODUCT Alaris PC unit, model 8015 with PC unit power supply board P/N TC10005122, manufactured after January 2011. Affected product was distributed from January 1, 2011, to May 31, 2012. The Alaris PC unit, model 8015 is part...
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Company:Sigma Date of Enforcement Report 7/25/12 Class lll: PRODUCT SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters. Recall Number Z-2030-2012 REASON Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with...
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Company:SIGMA International, LLCDate of Enforcement Report 6/18/12 Date Recall Initiated: July 6, 2011 Class l: PRODUCT SIGMA Spectrum Infusion Pump Model 35700. The SIGMA Spectrum Infusion Pump is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products through parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration....
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While FDA has oversight over Medical devices for vetinary use they are not treated like devices for human use. Generally a quality system although recommended is not required and unless the device emits radiation registration and listing is not required. Below is an excerpt from the FDA website: How FDA Regulates Veterinary Devices The Federal...
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Company:Medtronic Neuromodulation Date of Enforcement Report 4/11/12 Class ll: PRODUCT Medtronic, Model 8870, Application Software Card is part of the SynchroMed II Drug Infusion System. The System includes the SynchroMed II implantable drug infusion pump 8637-20, 8637-40, N’Vision clinical programmer 8840 and the Software application card 8870. The SynchroMed II Infusion system contains and administers...
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An article on the QMED website reporting on hacking of Medtronic Infusion pumps using remote wireless capability that could allow patient harm.
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http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm202511.htm
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Company: Hospira Inc. Date of Enforcement Report 10/26/11 Class ll: PRODUCT 1) Plum A+ Single Channel Infusion Pumps; The pumps were sold under the following configurations: a) list 11971 b) list 11973 – software version 10.3 c) list 12391 – software version 11.3 d) list 20679 – Hospira MedNet Software e) list 20792 – Driver...
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Company: B. Braun Medical, Inc..Date of Enforcement Report 8/24/10 Class l: PRODUCT Outlook 400ES Safety Infusion System Model number 621-400ES The B. Braun Outlook 400ES Safety Infusion System is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required....
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Company: Moog, Inc.Date of Enforcement Report 4/8/2011 Class l: Moog Incannounced today that the Food and Drug Administration (FDA) has classified the voluntary correction of the Curlin 6000 CMS, Curlin 6000 CMS IOD, PainSmart, and PainSmart IOD as a Class I recall. The affected models were manufactured and updated from May 2007 to February 2011....
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Company: Hospira IncDate of Enforcement Report 3/23/2011 Class ll: PRODUCT 1) Plum A+ Single Channel Infusion Pumps; the pumps were sold under the following configurations: a) list 11971 b) list 11973 – software version 10.3 c) list 12391 – software version 11.3 d) list 20679 – Hospira MedNet Software e) list 20792 – Driver The...
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Company: B. Braun Medical, Inc Date of Enforcement Report 1/24/2010 Class l: PRODUCT Outlook 400ES Safety Infusion System Model number 621-400ES Manufacturing From: May 21, 2009 – June 23, 2009 Distribution From: July, 24, 2009 – December 31, 2009 The recalled products were upgraded from May 4, 2010 – June 21, 2010. Use: The B....
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Company:Baxter Healthcare, Corp Date of Enforcement Report 11/17/10//2010 Class l: PRODUCT ) Baxter Colleague Single Channel Volumetric Infusion Pumps. Product Codes: 2M8151, 2M8161, and 2M9161. Recall # Z-0001-2011; 2) Baxter Colleague Triple Channel Volumetric Infusion Pumps. Product Codes: 2M 8153 and 2M 8163. Recall # Z-0002-2011; REASON The FDA sent a letter to Baxter on...
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Company: Smiths Medical ASD, Inc. Date of Enforcement Report 8/11//2010 Class ll: PRODUCT Medfusion Syringe Infusion Pumps, Models 3010 and 3010a with Software Versions 2.0.2, 2.0.3, AND 2.0.4 Medfusion Syringe Infusion Pumps are designed for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates. Recall # Z-2121-2010 REASON Smiths...
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/docs/FDAInfusionPumpDraftGuidance-042310-UCM209337.pdf
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Company:Picis IncDate of Enforcement Report 4/15//2010 Class:ll PRODUCT CareSuite” – Critical Care Manager, PACU Manager and Anesthesia Manager Software. Recall # Z-1252-2010 REASON Under specific timing of conditions and in configuration with 3rd party infusion pumps, an error within the clinical application causes the manual documentation of clinical orders to be changed to an automatic...
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Company:Smiths Medical.ASD Inc.Date of Enforcement Report 1/20/2010 Class:ll PRODUCT 1) Smiths Medical Medfusion model 3500 syringe Infusion pump, software version V3.0.6. Model 3500. Rx Only. Recall # Z-0650-2010; 2) Smiths Medical Medfusion model 3010a syringe Infusion pump. REF 3010A. Rx Only. Recall # Z-0651-2010 REASON Smiths Medical has become aware of an increased trend in...
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The Carnegie Mellon Software Engineering Institute continued work on safety assurance cases for medical devices by publishing a paper entitled “Towards an Assurance Case Practice for Medical Devices” doing an example case for an infusion pump. The full article is at the link provided. Although this is intended uses infusion pumps as an example it...
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Company:Hospira Inc.Date of Enforcement Report 9/2/2009 Class:ll PRODUCT 1) Hospira Phoenix Infusion System with MedNet Software, Symbiq One-Channel Infusion System, Software versions v2.1 & v3.0, Recall # Z-1815-2009; 2) Hospira Phoenix Infusion System with MedNet Software, Symbiq Two-Channel Infusion System, Software versions v2.1 & v3.0, Recall # Z-1816-2009 REASON Potential delay/under infusion of critical therapy–...
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Company: Cardinal HealthDate of Enforcement Report 8/26/2009 Class:l PRODUCT 1) The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) with software version 4 and above, Recall # Z-1790-2009; 2) The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) software version 8 and above when used with the...
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Company: Baxter Healthcare Corp Date of Enforcement Report 3/11/2009 Class:l PRODUCT Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps Model numbers: Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163 These products were manufactured and distributed from February, 1997 through December, 2008. REASON The company identified software and battery usage failures...
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Company: Smiths Medical MD, Inc Date of Enforcement Report 3/11/2009 Class:ll PRODUCT a) Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V3.0.6. The Medfusion 3500 pump is a small, lightweight and portable syringe infusion pup. The pump offers a variety of delivery modes to program to meet specific patient care needs. The Medfusion...
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Company:Baxter Healthcare CorpDate of Enforcement Report 1/23/2009 Class:l PRODUCT Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps REASON The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corp., Round Lake, Illinois
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Company:Baxter Healthcare CorpDate of Enforcement Report:7/25/2007 Class:l PRODUCT Baxter Colleague Triple Channel Volumetric Infusion Pumps; Made in Singapore, product codes 2M8153, 2M8163, 2M9163, Recall # Z-1091-2007 REASON A software anomaly is causing newly upgraded Colleague Triple Channel Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming...
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Company:Smiths Medical MD, Inc., . Date of Enforcement Report:5/2/2007 Class:ll PRODUCT Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4, Recall # Z-0768-2007 REASON Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump’s startup sequence when the pump’s Preventative Maintenance...
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Company:Smiths Medical MD, Inc., . Date of Enforcement Report:4/11/2007 Class:ll PRODUCT Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01 (PCS II) and 21-8821-01 (VIP); RX ONLY, Recall # Z-0718-2007 REASON The year of manufacture had been incorrectly entered as 1980 into the...
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Company:Alaris Products, FDA News FOR IMMEDIATE RELEASE P06-119 August 28, 2006 Media Inquiries: Catherine McDermott, 301-827-6242 Consumer Inquiries: 888-INFO-FDA United States Marshals Seize Defective Infusion Pumps Made by Alaris Products Pumps Can Deliver Excess Medication and Harm Patients At the request of the U.S. Food and Drug Administration (FDA), the U.S. District Court for the...
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Company: Baxter Healthcare Corporation,Date of Enforcement Report: 7/27/05 Class: I PRODUCT a) Baxter Colleague Single Channel Volumetric Infusion Pumps, product codes: 2M8151, 2M8151R, 2M8161, 2M8161R, Recall # Z-1022-05; b) Baxter Colleague triple Channel Volumetric Infusion Pumps, product codes: 2M8153, 2M8153R, 2M8163, 2M8163R, Recall # Z-1023-05 REASON The pumps may experience inadvertent power off, external communications...
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Company: Baxter Healthcare Corp.Date of Enforcement Report: 1/12/05 Class: II PRODUCT a) Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151 and 2M8151R; Made in Singapore; monochrome display screen. Recall # Z-0342-05; b) Colleague 3 Triple Channel Volumetric Infusion Pumps, product code 2M8153 and 2M8153R; Made in Singapore; monochrome display screen. Recall # Z-0343-05; c)...
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Company: Sooil Development Co. Ltd.Product:Insulin infusion pump Date: 11/24/04 Failure to document the results of the design validation in the design history file, as required by 21 CFR 820.30(g). For example, the documentation of the bolus and basal infusion testing involving the dispensing software was incomplete. Additionally, as part of your software validation, the report...
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Company: Medex, Inc.Date of Enforcement Report: 4/21/04 Class: III PRODUCT Medex 3000 Series Syringe Infusion Pumps. Recall # Z-0813-04. CODE Model numbers: 3010 (General use pump for use with 3cc to 60cc syringes, 3010a (Pump for use with 1 cc to 60cc syringes), 3010aE (Use with 1cc to 60cc syringes in UK), 3010aVX (Evaluation pump...
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Company: Harvard Clinical TechnologyDate of Enforcement Report: 9/17/03 Class: II PRODUCT Harvard 2, Dual Infusion Pump (P/N 2002-001). Recall # Z-1208-03. REASON Under specific sequence conditions, the unit may appear to be infusing, but is not. CODE Software versions V1.2R or earlier. RECALLING FIRM/MANUFACTURER Harvard Clinical Technology, South Natick, MA, by letter on August 11,...
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Company: Medex, IncDate of Enforcement Report: 8/6/03 Class: II PRODUCT Medex 2000 Series Syringe Infusion Pumps. The 2001 series is a general use pump, 2001E is for German use, 2001G is for use in the UK, 2001T is for use in Taiwan, 2010iK is for use in Korea, (the pumps with different languages have different...
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Company: Deltec, Inc.Date of Enforcement Report: 7/23/03 Class: II PRODUCT Deltec CASS-Prizm PCS II Ambulatory Infusion Pump with Revision E Software. Recall # Z-0980-03. REASON Pump keyboard entries by the patient can result in the patient having unintended access to programming screens and result in improper drug dosage. CODE Pump Serial numbers 658825, 658837, 658840,...
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Company: Abbott Laboratories, IncDate of Enforcement Report: 5/28/03 Class: II PRODUCT a) Gemstar_ 7 Therapy I.V. Infusion Pump, List#: 13000-04; 2.9 Software Version. Recall # Z-0792-03; b) Gemstar_ 6 Therapy I.V. Infusion Pump, List#: 13100-04; 2.9 Software Version. Recall # Z-0793-03; c) Gemstar_ Therapy Pain Management I.V. Infusion Pump, List#: 13150-04; 2.9 Software Version. Recall...
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Company: Baxter Healthcare CorpDate of Enforcement Report: 7/31/02 Class: II PRODUCT Baxter Ipump Pain Management System infusion pump, product codes 2L3107 and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL. Recall # Z-1166-2. REASON Software anomaly allows access to change prescription or program bolus without security. CODE Product codes 2L3107 and 2L3107R, all serial numbers. RECALLING FIRM/MANUFACTURER...
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IMED Gemini PC-4 Volumetric Infusion Pump and Controller withVersion 1.85 Software: a) PC-4 Infusion Pump, Model 1340, 110 volts; b) PC-4 Infusion Pump, Model 1341, 220 volts. Recall #Z-174/175-0. REASON Due to a software modification, the devices will stop infusing and alarm if the processors receive conflicting or confusing messages. CODE All pumps that carry...
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4/16/99 Class II Colleague 3 Volumetric Infusion Pump (Triple Channel). Baxter Healthcare 6,992 units. A software communication error occurs predominately when all three channels are in use, causing an alarm codition that will stop the function of all of the channels in use. The pump will alarm appropriately, alerting the user of the failure state....
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Ultramedic Ltd. 11/25/98 Infusion Pump Analyzers 6. Failure to have an established protocol to validate computer software for its intended use when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, there is no validation protocol for the validation study...
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9/4/98 Nera Electronics/Baxter Healthcare Flo Gard 8200 Volumetric Infusion Pump: Class II 13 units. Board assemblies had the wrong software version installed on them. The boards have version 2.09 instead of version 2.13. Recall #=-Z-777-8.
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Sabratek Corp. 8/19/98 Infusion pumps 1. Failure to identify the actions needed to correct and prevent recurrence of non-conforming product. For example, it was determined that the _____ had a software problem which prevented the infusion rate from exceeding the bolus rate while operating in the “PCA” mode. While the software has been revised, the...
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9/30/97 EZ-Flow 480 Ambulatory Infusion Pump 1058 devices. Defective software may cause over infusion when using the PCA mode. 1/9/98 confirmed a patient death due to a software logic error related to use in the patient controlled analgesia (PCA) mode caused the lethal dose of morphine sulfate. Two non-fatal incidents in 1996 also occurred.
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McGaw Stratus Ambulatory Infusion System Model 550 and Alphamed EZ Pump, Model 550 withSoftware Version 2.32.00/2.42.01. Recall #Z-188-9. REASON The pump could under infuse or blood could back up into IV lines when the pumps are running at a slow flow rate with a large infusion set. CODE Serial Numbers: P61145, P71108, P71115, P71125, P71130,...
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