BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEHEART PUMP

    MDR report key: 3843763 · Received May 23, 2014

    Report

    Report Number
    2531527-2013-00004
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 25, 2013
    Report Date
    May 23, 2014
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    KFM
    PMA / PMN Number
    K991783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4). ON (B)(6) 2013, (B)(6) RECEIVED INFO OF PROBLEMS WITH A TANDEMHEART SYSTEM. PER (B)(6)..."(B)(6) DID A CASE LATE LAST NIGHT THAT DIDN'T GO SO WELL... THE PT WAS DOING FINE AND ARRESTED UNEXPECTEDLY (PRIOR TO TANDEMHEART USE) SO IT WAS EMERGENT PRIMING AND IMPLANTATION. THERE WERE NEW CIRCULATORY SUPPORT TECHNICIANS IN THE ROOM THAT MAY HAVE CONTRIBUTED. FURTHER DISCUSSION BETWEEN MR SEARS AND ANDRE AT THE SITE CONFIRMED THAT THE LIKELY CAUSE WAS USE OF THE SYSTEM IN AN EMERGENT SITUATION WITH A CRASHING PT, AND NEW TECHNICIANS THAT STRUGGLED WITH SETUP UNDER PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308634 TANDEHEART PUMP NON-ROLLER BEARING BYPASS PUMP KFM CARDIAC ASSIST, INC. 5120-0000 00146092

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention