BEUDAMED
    FDA Adverse Event Death Summary report: N

    TANDEMHEART SYSTEM

    MDR report key: 2728840 · Received August 31, 2012

    Report

    Report Number
    2531527-2012-00003
    Event Type
    Death
    Date Received
    August 31, 2012
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    KFM
    PMA / PMN Number
    K991783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TANDEMHEART SYSTEM COMPONENTS WERE NOT RETURNED FOR EVAL. PER THE INFO PROVIDED BY THE HOSP, NO MALFUNCTION OF ANY OF THE COMPONENTS OF THE TANDEMHEART SYSTEM WAS OBSERVED, NOR COULD HAVE REASONABLY LED TO THE COMPLICATIONS ASSOCIATED WITH THE FEMORAL ARTERIAL CANNULA. THE BLOOD LOSS DUE TO DISLODGEMENT AND EXCESSIVE BLEEDING AT THE FEMORAL ARTERIAL CANNULA SITE WAS DETERMINED TO BE THE ROOT CAUSE OF THE INCIDENT. THE FEMORAL ARTERIAL CANNULA IS NOT MFG BY OR DISTRIBUTED BY CARDIACASSIST.

    Description of Event or Problem · 1

    ON (B)(6) 2012, CARDIACASSIST WAS NOTIFIED OF AN ARTERIAL DISLODGEMENT AND DEATH THAT OCCURRED TO A PT SUPPORTED BY THE TANDEMHEART SYSTEM. IT WAS REPORTED THAT DURING TANDEMHEART CARDIOPULMONARY SUPPORT, A COVERING HAD BEEN PLACED OVER THE FEMORAL ARTERY CANNULATION SITE. AT SOME POINT, THE CANNULA BECAME DISLODGED AND THE PT DIED FROM EXSANGUINATION BEFORE THE BLEEDING COULD BE CONTROLLED. THE FEMORAL ARTERIAL CANNULA IS NOT MFG OR DISTRIBUTED BY CARDIACASSIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEMHEART SYSTEM NON-ROLLER BEARING BYPASS PUMP KFM CARDIAC ASSIST, INC. 5120-0000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death BIOMEDICUS, OR EDWARDS| FEMORAL ARTERIAL CANNULA, EITHER FROM MEDTRONIC,