BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC

    MDR report key: 86582 · Received July 5, 1996

    Report

    Report Number
    86582
    Event Type
    Injury
    Date Received
    July 5, 1996
    Date of Event
    February 17, 1996
    Report Date
    April 1, 1996
    Manufacturer
    THORATEC LABORATORIES, CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE COVERING HOUSING OVER THE AIR DIAPHRAGM OF THE PUMP BECAME DETACHED FROM PUMPING CHAMBER. PT DEVELOPED SHOCK LIKE CONDITION AND PULMONARY EDEMA. RETURNED TO OPERATING ROOM MFR NOTIFIED AND BEGAN INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC Implant LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC LABORATORIES, CORP. UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention