BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 61110 · Received December 30, 1996

    Report

    Report Number
    2916596-1996-00011
    Event Type
    Malfunction
    Date Received
    December 30, 1996
    Date of Event
    November 29, 1996
    Report Date
    December 20, 1996
    Manufacturer
    THORATEC LABORATORIES CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THORATEC HAS REPLACED THE TWO-PIECE EMERGENCY HAND BULB WITH A ONE-PIECE SEAMLESS DESIGN. THIS CHANGE WAS SUBMITTED TO THE FDA IN PMA P870072/S006 & APPROVED ON 1/21/98. EMERGENCY HAND BULB PUMPS WITH THE SEAMLESS DESIGN ARE CURRENTLY BEING ASSEMBLED FOR DISTRIBUTION TO THE FIELD AS REPLACEMENTS FOR THE EXISTING EMERGENCY HAND BULB PUMPS.

    Description of Event or Problem · 1

    A DRIVE CONSOLE WITH A KNOWN WEAK BATTERY WAS BEING USED TO SUPPORT A PT WITH THE DEVICE. RATHER THAN SWITCH THE PT TO ANOTHER DRIVE CONSOLE WITH SUFFICIENT BATTERY POWER, THE HOSP STAFF ELECTED TO USE THE EMERGENCY HAND-BULB PUMP TO OPERATE THE BLOOD PUMP DURING PT TRANSPORT. AFTER ABOUT 5 MINUTES OF USE, THE HAND-BULB DEVELOPED APPROX A 3CM SPLIT, MAKING IT UNUSABLE. ANOTHER HAND-BULB WAS CONNECTED TO THE BLOOD PUMP WITHOUT INCIDENT OR ANY NOTICEABLE EFFECT ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM Implant VENTRICULAR ASSIST DEVICE: EMERGENCY HAND-BULB PUMP DSQ THORATEC LABORATORIES CORP. NA WO3676

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention