BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEMHEART PUMP

    MDR report key: 692666 · Received March 23, 2006

    Report

    Report Number
    2531527-2006-00001
    Event Type
    Malfunction
    Date Received
    March 23, 2006
    Date of Event
    March 4, 2006
    Report Date
    March 13, 2006
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AFTER APPROX 10 DAYS OF SUPPORT, THE CLINICAL STAFF OF THE UNIVERSITY MEDICAL CENTER- TUSCON, EXPERIENCED A HIGH LUBE PRESSURE ALARM CONDITION ON THE TANDEMHEART SYSTEM CONTROLLER AND THE TANDEMHEART PUMP STOPPED. THE VAD COORDINATOR AT THE HOSPITAL INDICATED THAT THE PUMP LUBE PRESSURE WAS VERY HIGH. THE PT WAS REMOVED FROM TANDEMHEART SUPPORT AND WAS NOT ADVERSELY IMPACTED BY THE INCIDENT. THE TANDEMHERAT SYSTEM IS CURRENTLY APPROVED FOR 6 HOUR USE.

    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