BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEMHEART PUMP

    MDR report key: 1013979 · Received March 12, 2008

    Report

    Report Number
    2531527-2008-00002
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 22, 2008
    Report Date
    March 10, 2008
    Manufacturer
    CARDIACASSIST, INC.
    Product Code
    KFM
    PMA / PMN Number
    K991783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AN EVALUATION 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 HOSPITAL CONTACTED CARDIACASSIST TO REPORT THAT A PUMP HAD STOPPED AFTER 7 DAYS OF USE. THE PATIENT'S ANTI-COAGULATION HAD BEEN DISCONTINUED THE DAY PRIOR TO THE INCIDENT. THE PUMP AND SYSTEM CONTROLLER WERE REPLACED WITHOUT INCIDENT. THE PATIENT 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 CARDIACASSIST, INC. TANDEMHEART

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention