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Diasorin, Saluggia Italy 23-Dec-99 production/QC software validation for reagents”8. Failure to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use [21 CFR 820.70(g)] in that the Gamma Counter Data Transfer Validation, dated March 31. 1999. did not...
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REASON Software may incorrectly link previous assay results to a different patient ID. PRODUCT Chiron Diagnostics Automated Chemiluminescence System, Model ADVIA:CENTAUR for the quantitative determination of various in vitro diagnostic assays using direct chemiluminescent technology. Recall #Z-358/359-0. CODE Catalog Numbers: 114564, 572561, 572562, 572563, 572564, and 572566. All ADVIA:Centaur Immunoassay Analyzers with software versions 2.01...
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PRODUCT AcQ Plan, 3-D Radiation Therapy Treatment Planning System (software), a software option for the Computed Tomography (CT) Scanners. Recall #Z-300-0. REASON Software anomaly causes the isocenter shift to be labeled incorrectly. CODE All units using the AcQPlan Therapy Planning software version 4.04 are affected. MANUFACTURER Marconi Medical Systems, Inc., Highland Heights, Ohio. RECALLED BY...
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7. Failure to maintain complete and adequate written SOPS that reflect current bloodbank operations as requiredby21 CFR 606.100(b) and 606.60. For example, with respect to the computer system in use, there were no SOPS available for security procedures for unauthorized access, review of the system and correction of errors, and control of changes in hardware...
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3d) Standard operating procedure Routine Release of Crossmatched Blood and Blood Products has not been updated to include computter operations utilizing xxx Blood Bank and Blood Donor Computer System versionyyyy. Specifically, the procedure does not include what type of second verification of information entered into the computer should be performed when blood products are released...
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Status of FDA permission requirements for Blood Bank establishment use of electronic crossmatch as of November 18, 1999: Because 21 CFR 606.151 requires a serologic crossmatch those hospitals (all hospitals) who wish to use the electronic crossmatch must apply for a variance to 21 CFR 606.151 (as allowed by 21 CFR 640.120) to gain written...
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PRODUCT Mini-Med MMT-508 Insulin Pump, indicated for the continuous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. Recall #Z-288-0. REASON The pump’s software has an error in which the current basal rate profile indicated on the pump display, was a rate programmed for earlier in...
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Failure to validate the EtO sterilization process for ATI plasma exchange tubing setsand off-the-shelf software for compiling clinical trial data. Also there are no procedures established and maintained for monitoring and controlling the process parameters for the ATI plasma exchange tubing sets to ensure that specified requirements are met as required by 21 CFR 820.75....
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Published November 1999 in “Pharmaceutical Tecnology” was the the article “Using New Techniques for Reducing System Validation Time and Cost”. This article described an approach used in an Eli Lilly drug plant for validation of PLCs and an Intellution system where many similar but slightly different programs and pieces of manufacturing equipment were used. Its...
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100 copies. Pato Brachytherapy Treatment Planning System Version 13.2 and higher. Software Implementation Error. Z-039-0/
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REASON The software validation of version 4.01R1 a software anomaly was found that affected the proper function of a print option. PRODUCT Vitalcom ST Segment Arrhythmis Detection Software Option, an Optional ECG software feature used in conjunction with the Critikon Observer Central Station on which is installed. There are 12 models or catalog numbers of...
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PRODUCT Model 250 NeuroCybernetic Prostheses (NCP) Programming Software Versions a) 4/1; b) 4.4, implanted autonomic nerve stimulator for he treatment of epilepsy. REASON The label insert sheets were printed with the incorrect lot number. CODE Lot numbers a) 23952C; b) 26023C, 27137C, 27735C. Recall #Z-570/571-0. MANFACTURER Cyberonics, Inc., Inc., Houston, Texas. RECALLED BY Manufacturer, by...
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Mountain View Blood Bank 10/5/99 The _____ Procedure, Revision Date 10-26-94, required donors who test repeatedly reactive for HTLV- 1/2, HIV, HBsAg and HCV to be permanent y deferred and the donors notified. Employees lacked adequate training because they were not following this procedure [21 CFR 606.20(b)]. The donor deferral files were not adequate to...
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Failure to review and evaluate all complaints and maintain a record of the reason no investigation was made and the name of the individual responsible for the decision not to investigate; failure to maintain records that demonstrate that each batch, lot, or unit of device meets in-process or finished device specifications; failure to validate and...
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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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223 units. 740 ventilator system and ventilator 760 system. Any Ventilator will revision J. software. Software can cause under or over delivery of oxygen. Z-170/171-0
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The New England Biomedical Discussion Group held a half-day seminar on Risk Management. Alan Kusinitz of SoftwareCPR gave a presentation on Software Risk Management. The newsletter summary of the seminar is at the link provided: Intro to Risk Management Article
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6. Failure of the DMR (device master record) to include device specifications including appropriate drawings, composition, formulation, component specifications and software specifications, as required by 21 CFR 820.181(a). For example:
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CRS-USA LASIK 8/18/99 Clinical Trial Software Validation There was no verification that the data submitted by the clinical investigators matched source data at the site. The only data verification was performed by the computer data service, xxxx and involved scrutinizing the data for such errors as out-of-range data, field entry omissions, exam dates out-of-range, and...
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South Florida Blood Bank 8/12/99 The inspection revealed that complete and accurate donor deferral records are not being maintained. A deferred donor that tested repeatedly reactive HBsAg on February 12, 1998 (Unit #2251435) was improperly re-entered for donation on August 12, 1998 without a neutralization test being performed. This donor should have remained in deferral....
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Nucletron Plato External Beam Planning Radiation Therapy SoftwareV2.1.2 and MLC/Shape Software Module V2.3 Recall #Z-038-0. REASON Coordinates for radiation beam used in therapy are mislabeled in software. CODE Plato RTS software version V2.1.2 used with software module MLC/Shape version V2.3. MANUFACTURER Nucletron BV, The Netherlands. RECALLED BY Nucletron Corporation, Columbia, Maryland, by letter and customer...
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11 systems. Acqplan Radiation Therapy Planning System. A software option for computed tomography scanners. An incorrect calculation of ISO/N dosage may result when changing parameters. Z-1236-9
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Drager Medizintechnik GmbH, 6-Aug-99, Intensive care ventilators, anesthesia and incubators 1. Failure to validate computer software used as part of the quality system for its intended use according to an established protocol as required by 21 CFR 820.70(i). For example, the data in the Excel spreadsheet identified as a “Hit List” of top nonconforming components...
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Vitalograph Ltd., 6-Aug-99, Spirometers and peak flow meters 4. Failure to establish and maintain process control procedures for the monitoring and control of process parameters during production, as required by 21 CFR 820.70(a) and (b). For example, the firm failed to measure the temperature of the wave-soldering machine at the start of every PCB Kit...
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Linweld 8/2/99 Significant deviations include, but may not be limited to the following: Failure to maintain a computer system with validated program capabilities for operating a medical gas facility [21 CFR 1-11.68]. Examples include: No testing of the system after installation at the operating site. Operating sites are part of the overall system and lack...
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Company: Gensia Sicor Pharmaceuticals Inc.Date: 7/21/99 Product: Drug Products Failure to maintain laboratory records to include complete data derived from all tests necessary to assure compliance with established specifications and standards [21 CFR 211.194]. Specifically, your firm failed to properly maintain electronic files containing data secured in the course of tests from 20 HPLCs and...
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7-July-99 Olympus. Class III field correction. EPROM Version 3.00 Software for the Olympus EVIS CV-140 Video System Center. The device has a malfunction due to incorrect coding of the software which can cause the software to overwrite the patient ID number with any comments that are entered by the user.. Z-1227-9IVD
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“A Software Development Process Model for Artificial Neural Networks in Critical Applications” by David M. Rodvold Colorado Technical University and Xaim Inc.presented at the International Joint Conference on Neural Networks (IJCNN’99). Washington D.C. July 1999. In this paper Mr. Rodvold addresses the challenges of using neural networks in critical applications and describes an approach to...
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Novartis 7/1/99 b. The annual product reviews did not include all stability results. A problem in the firm’s computer system prevented the results of stability data from printing. Additionally, the stability data from these annual reviews was used to support the Tegretol XR expiration date extension. SoftwareCPR keywords: drugs, pharmaceuticals, computer validation
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30-June-99 C30-June-99 Kavo Dental 7 units. Class III. AC powered dental drilling device. Software error may cause unit to shutdown prior to reaching preset torque limit. Z-1215-9
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Prucka 30-June-99 Multi-channel electrocardiographic amplifiers, CardioLab EP System and CardioCath Catheterization Lab System software 2. Failure to establish and maintain procedures for validation of the device design, including software validation, and documentation of the validation, as required by 21 CFR 820.30(g). For example: a. Standard operating procedures have not been established for software validation. b....
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28-June-99 Quinton Instruments 11 review stations and 7 Sequence NIS stations. Class II.Under certain specific circumstances,sequences of a single plane study, may overlap sequences of bi-plane study when viewing both on the Angiocomm Single Sequence Review Station or the Single Sequence Network Interface Station (NIS). Z-1116/1119-9
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Solvay Pharmaceuticals 6/23/99 Computer System Validation 1. The xxxx computer system, used to monitor and maintain such critical systems as the xxxx and xxxx systems, has not been validated. Our inspection revealed that the xxxx computer system is used to monitor temperature, conductivity, water pressure and time (in hours) for replacement of xxxx for the...
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6/22/99 Bayer Corporation 3767 units. Class III Technicon SETpoint Chemistry Calibrator. During review of the value assignment procedure it was learned that the operator manually entered intercept corrected SETpoint values into an Excel spreadsheet rather than letting the spreadsheet calculate the corrections from the true SETpoint. The values that were entered were incorrect and, therefore,...
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6/14/99 Cardiopulmonary Corporation 59 units. Class II Venturi Ventilator with hard drive. User interface software will not load when unit is first powered on. Z-1039-9
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Defense Blood Standard System (DBSS), Blood Bank Software. Recall #B-1094-9. REASON Blood bank computer software does not identify all potential duplicate donor records. CODE Software Versions 3.00 and 3.01. MANUFACTURER Electronic Data Systems (EDS), Herndon, Virginia. RECALLED BY U.S. Department of Defense (DBSS)Composite Health Care System 2, Falls Church, Virginia, by E-mail on June 9...
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Boehringer Mannheim/Hitachi 917 Disk System, a clinical chemistryanalyzer system. Recall #Z-1040-9. REASON The barcode reader can read the wrong sample barcode, mismatch the test results, and report them under the wrong sample. CODE All versions of the disk system software with an updated barcode reader. This includes the system with Serial No. 9715-05 and all...
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/Docs/FDApresentationonPart11ANDClinicalTrialsSW.pdf
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5/21/99 VIA Medical Corporation 59 units. Class II VIA Low Volume Mode (LVM) Monitor. The devices has a software problem that can cause the monitor, under unusual circumstances, to display and print a chemistry value from a previous sampling instead of the blood chemistry value from the current sampling. Z-1041-9.
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14. Failure to validate the software programs, Shimadzu and _____ that are used to run the laboratory HPLC equipment, during analysis of raw materials and finished products. The _____ software does not secure data from alterations, losses, or erasures. The software allows for overwriting of original data. There are no written procedures for the use...
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