BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC

    MDR report key: 1275446 · Received December 22, 2008

    Report

    Report Number
    MW5009407
    Event Type
    Injury
    Date Received
    December 22, 2008
    Date of Event
    December 12, 2008
    Report Date
    December 22, 2008
    Manufacturer
    THORATEC
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A MALE WITH ISCHEMIC CARDIOMYOPATHY. S/P HEARTMATE II LVAD IMPLANT IN 2008. ROUTINE POST-OP COURSE. DISCHARGED THE FOLLOWING MONTH. SIXTEEN DAYS LATER, READMITTED AND DIAGNOSED WITH PERICARDIAL EFFUSION AND PNEUMONIA. S/P DIURESIS. DISCHARGED THE FOLLOWING MONTH. FOUR DAYS LATER, CALLED PHYSICIAN OFFICE WITH COMPLAINTS OF LEFT SIDE CHEST PAIN - 6/10-AND NAUSEA. PUMP WAS NOT ALARMING, FLOWS WERE +++, PI: 1.3-1.7 RANGE; PUMP POWER 13. INR 1.3. ADVISED TO GO TO LOCAL ER. IN THE ER, PUMP POWER 17, BP NORMAL -MAP 70-. MANUFACTURER NOTIFIED OF PUMP FAILURE. PATIENT INTUBATED, RECEIVED TPA, EPI DRIP, AND HEPARIN. S/P EMERGENT PUMP REPLACEMENT. OUTCOME: NEUROLOGICALLY INTACT, EXTUBATED POD #2, NO CURRENT PUMP PROBLEMS. BACK-UP SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC HEARTMATE II LVAD DSQ THORATEC VAD 5106 73706

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| S