BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (DDC)

    MDR report key: 2508672 · Received March 27, 2012

    Report

    Report Number
    2916596-2012-00256
    Event Type
    Malfunction
    Date Received
    March 27, 2012
    Date of Event
    February 26, 2012
    Report Date
    February 27, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SERVICED ON SITE BY THE MANUFACTURER'S TECHNICAL SERVICES TECHNICIAN AND THE REPORTED EVENT WAS CONFIRMED. THE CONSOLE WAS INSPECTED AND WAS FOUND TO FUNCTION, HOWEVER, THE UNINTERRUPTED POWER SUPPLY (UPS) BECAME WARM TO TOUCH. VISUAL INSPECTION REVEALED DEBRIS ON THE UPS FAN GUARDS AND ON THE FRONT AIR GRILL. THE DEBRIS WAS REMOVED AND THE UNIT WAS CLEANED. THE UNIT WAS THEN FUNCTIONALLY TESTED OVER A PERIOD OF FOUR DAYS AND WAS FOUND TO FUNCTION AS INTENDED. THE UNIT DID NOT BECOME WARM TO TOUCH THROUGHOUT THE FOUR DAY TESTING PERIOD, AND WAS, THEREFORE, RETURNED TO SERVICE. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS, AND THE DEVICE WAS LAST SERVICED IN (B)(6) 2011. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THAT OVER THE LAST TWO DAYS, THE DUAL DRIVE CONSOLE (DDC) HOUSING WAS VERY WARM AND STARTED TO EMIT SMOKE AND A BURNING ODOR WAS NOTED. THE DDC STOPPED AND THE ICU NURSE IMMEDIATELY SWITCHED TO HAND PUMPING AND THEN TO THE BACK-UP DDC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (DDC) DSQ: VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. L10025-2600-007

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other