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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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Abbott Alcyon Analyzers with Alcyon System Software Version 1.6.Recall #Z-267-0. REASON The device may give incorrect tests results or reference ranges when printing the “Complete Report (header)”, “Incomplete Report (DRAFT)”, and the “Control Results printout.” CODE List #4E73-04. MANUFACTURER Abbott Laboratories, Inc., Irving, Texas. RECALLED BY Manufacturer, by telephone on May 18 and 19, 1999,...
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5/18/99 Cardiopulmonary Corporation 1 unit. Class II Venturi Ventilator Software revision C. Software error may cause ventilator to deliver more than set tidal volume. Z-803-9
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Picker 7-May-99 MRI equipment The following, deviations from the Device Quality System Regulations were documented: 1) Failure to maintain a design file necessary to demonstrate that the design was developed in accordance with the approved design plan as required by 21 CFR 820.30(j). For example, there is no documentation of any module testing of the...
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Failure to investigate the cause of nonconformities relating to product, processes and the quality system; failure to develop, conduct, control and monitor production processes to ensure that a device conforms to its specifications; failure to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have...
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Incomplete records for all blood components produced; failure to routinely review error messages on computer system. The inspection also revealed that _____ error messages on your computer system are not routinely reviewed, processed, and investigated to determine final disposition. The instructions for computer system training do not include a clear written explanation of what error...
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4/30/99 Bayer Diagnostics 1000 units. Class II ADVIA 120 Hematology System When running the ADVIA 120 system in the manual mode using the Host Query feature and the timeout is set to 13 seconds, it is possible for the system to report incorrect patient results. The supplemental labeling instructions section of the product labeling instructs...
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With regard to FDA-483 Item 4, Braun was cited for not reporting two MDR reportable complaints, Mfr reports #1641965-1998-00018/24, to FDA within the 30 days time frame. Your response indicated that Braun is currently changing the complaint handling system from tracking complaint information on an _____ spreadsheet to using an off-the-shelf database system, _____ tracker....
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B) Failure to validate the computer system controlling the air separation process.
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Failure to exercise appropriate controls over computer or related systems to ensure that changes in records are instituted only by authorized personnel; failure to concurrently maintain a record from which unsuitable donors may be identified; and failure to maintain and/or follow standard written operating procedures to include all steps to be followed in the collection,...
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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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All Architect I System Processing Modules with Software Versions1.0 and 1.01. Recall #Z-910-9. REASON The device may report incorrect results for diluted samples; and/or when used with the Laboratory Information System or Host Information Systems, the system may incorrectly associate test results with patient ID or incorrectly associate control results with patient records. CODE List...
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GE 9-April-99 Solar Model 7000/8000 Patient MonitorsJohn Welch, Jr. Chief Executive Officer General Electric Company 3135 Easton Turnpike Fairfield, Connecticut 06431 Dear Mr. Welch: We are writing to you because on March 8-12, 1999, investigators from the Food and Drug Administration (FDA) collected information from your Marquette Medical Systems, Milwaukee, WI, facility that revealed a...
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REASON Defective software could result in failure to give warning. CODE Version V1.4 and all previous versions of the software. MANUFACTURER Marquette Medical Systems, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by telephone and letter sent on April 8, 1999. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide, Canada, France, Australia, Italy, Sweden. QUANTITY 368 units were distributed.
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Donor Management Information System, Version 1.2. Recall #B-602-9. REASON Y2K defect in the computer software incorrectly calculates the end date of a temporary deferral to be 1900 instead of 2000, and removes the deferral from the database. CODE 11 systems were distributed. MANUFACTURER Information Data Management, Rosemont, Illinois. RECALLED BY Manufacturer, by telephone on January...
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4/6/99 Class II Phillips Medical 1086 units. Integris family of x-ray controls and generators (fluoroscopy,, urology, cardiology). The defect occurs when the system is driven to maximum EER and the source to image receptor distance (SID) is moved toa shorter distance while continuing to make exposures. In this manner of operation, the output may exceed...
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The Center for Devices and Radiological Health (CDRH), Office of Compliance, Division of Enforcement I, Diagnostic Devices Branch has reviewed the January/February 1999 Establishment Inspection Report of your firm, and the Form FDA 483 dated February 5, 1991, that was issued to you at the close of the FDA inspection. They also reviewed your product...
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