BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE STROKE VOLUME LIMITER

    MDR report key: 454477 · Received April 15, 2003

    Report

    Report Number
    2916596-2003-00013
    Event Type
    Death
    Date Received
    April 15, 2003
    Date of Event
    March 17, 2003
    Report Date
    March 18, 2003
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT ON PNEUMATIC SUPPORT WAS NOT RECEIVING OPTIMAL SUPPORT AND THE HOSPITAL BELIEVED THE CAUSE WAS A LEAK IN THE STROKE VOLUME LIMITER. THE HOSPITAL HAD GONE THROUGH DIAGNOSTIC TESTING OF THE STROKE VOLUME LIMITER (SCL) TO TEST FOR LEAKS AND THE PHYSICIAN WAS NOT CONVINCED THAT IT WAS NOT THE FAULT OF THE SVL BECAUSE THEY HAD NOT HAD THE SAME ISSUES SINCE SWITCHING THE PT TO A DIFFERENT SVL. THE HOSPITAL SWITCHED THE SVL AND THE PT SUFFERED NO ILL EFFECTS. THE PT REMAINS ONGOING ON PNEUMATIC ACTUATION. THE SVL WAS RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE STROKE VOLUME LIMITER STROKE VOLUME LIMITER DSQ THORATEC CORPORATION 1295 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Death