BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEMHEART PUMP

    MDR report key: 1030434 · Received April 16, 2008

    Report

    Report Number
    2531527-2008-00004
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 15, 2008
    Report Date
    April 10, 2008
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    KFM
    PMA / PMN Number
    K991783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: AN EVAL WAS CONDUCTED UPON RECEIPT WHICH CONFIRMED THAT THE PUMP WAS NON-FUNCTIONAL. ANALYSIS OF THE PUMP FOUND EVIDENCE OF BLOOD IN THE LOWER HOUSING OF THE PUMP, AS WELL AS DAMAGE TO THE INTERNAL BEARING COMPONENTS WHICH RESULTED IN THE PUMP FAILURE. SUCH DAMAGE HAS BEEN PREVIOUSLY DEMONSTRATED TO RESULT FROM LOSS OF INFUSION FLOW THROUGH THE BEARING PORTIONS OF THE PUMP. THE CAUSE OF THE LOSS OF INFUSION FLOW COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 1

    THE CLINICAL STAFF OF THE HOSP CONTACTED CARDIAC ASSIST TO REPORT THAT A PUMP HAD STOPPED AFTER APPROX 7 DAYS OF USE. THE SYSTEM CONTROLLER WAS REPLACED AND THE PUMP WAS RESTARTED, BUT SUBSEQUENTLY STOPPED AGAIN. PRIOR TO THE INCIDENT, IT WAS NOTED THAT THE PT'S PTT HAD NOT BEEN MAINTAINED WITHIN THE RECOMMENDED LEVEL OF 65 TO 80 SECONDS. THE PUMP AND SYSTEM CONTROLLER WERE REPLACED WITHOUT INCIDENT. THE PT WAS NOT ADVERSELY IMPACTED BY THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEMHEART PUMP NON-ROLLER TYPE BYPASS PUMP KFM CARDIAC ASSIST, INC. TANDEMHEART

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention