BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 297297 · Received September 21, 2000

    Report

    Report Number
    MW1019975
    Event Type
    Injury
    Date Received
    September 21, 2000
    Date of Event
    August 29, 2000
    Report Date
    August 30, 2000
    Manufacturer
    THORATEC LABORATORIES CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 12/13/00: THORATEC CONSIDERS THIS REPORT TO BE AN ISOLATED INCIDENT - THE FIRST OF ITS KIND IN ITS 18 YEARS OF CLINICAL EXPERIENCE WITH THE DDC. THE FAILED DDC WAS RETURNED TO THORATEC FOR FAILURE INVESTIGATION. INITIAL INVESTIGATION REVEALED THAT THE UNINTERRUPTIBLE POWER SUPPLY (UPS) SYSTEM HAD SUFFERED SEVERE DAMAGE, REQUIRING REPLACEMENT. TESTING OF THE ELECTRICAL SYSTEM OF THE DDC ALSO SHOWED INTERMITTENT AC VOLTAGE SPIKES IN THE OUTPUT OF THE DDC ISOLATION TRANSFORMER. THE TESTING, IN WHICH THE FAILURE WAS REPRODUCED, IMPLIES THAT THE FAILURE IS DUE TO A FAULT IN THE DEVICE AND NOT TO USER ERROR OR ENVIRONMENTAL CONDITIONS.

    Description of Event or Problem · 1

    THORATEC VAD CONSOLE SUDDENLY STARTED SMOKING AND LOST ALL POWER. OPERATORS SWITCHED TO MANUAL VAD INFLATION. THE UNINTERRUPTABLE POWER SUPPLY APPEARS TO HAVE HAD A MASSIVE FAILURE. THIS IS THE SECOND FAILURE OF THIS EXACT TYPE. PREVIOUS FAILURE OCCURRED FOUR MONTHS AGO. THORATEC SUPPLIED REPLACEMENT UPS AT THAT TIME. THORATEC FULLY INSPECTED UNIT ON 7/20/00, AND REPLACED SOME PARTS NOT RELATED TO THE UPS. THIS CONSOLE HAS HAD 4 FAILURES SINCE 1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA VENTRICULAR ASSIST DEVICE DSQ THORATEC LABORATORIES CORP. 2600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening| R