BEUDAMED
    FDA Adverse Event Death Summary report: N

    TANDEMHEART

    MDR report key: 1873137 · Received October 1, 2010

    Report

    Report Number
    1873137
    Event Type
    Death
    Date Received
    October 1, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 1, 2010
    Manufacturer
    CARDIAC ASSIST, INC
    Product Code
    KFM
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TANDEMHEART PLACED (B)(6) 2010. PT REMAINED ON HIGH LEVEL PRESSOR AND INOTROPE THERAPY, INTUBATED/VENTILATED AND SEDATED. HE WAS NONOLIGURIC IN PERSISTENT RENAL FAILURE REQUIRING DIALYSIS. ATTEMPTS TO WEAN FROM TANDEMHEART WERE UNSUCCESSFUL RESULTING IN DROP IN CARDIAC OUTPUT AND INDEX. PT ALSO HAD VENTRICULAR ARRHYTHMIAS AND PERSISTENT COAGULOPATHY. AT APPROXIMATELY (B)(4) ON (B)(4)2010 THE TANDEMHEART STOPPED FUNCTIONING FOLLOWED BY HEMODYNAMIC COMPROMISE. THE PT EXPIRED AT 0844.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEMHEART EXTERNAL LVAD KFM CARDIAC ASSIST, INC EC1000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death IJ CATHETER| DIALYSIS| ARTERIAL LINE| PLEASE REFER TO ATTACHED REPORTS FOR ADD'L INFO.| VENTILATION