BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEMHEART PUMP

    MDR report key: 650288 · Received December 2, 2005

    Report

    Report Number
    2531527-2005-00003
    Event Type
    Malfunction
    Date Received
    December 2, 2005
    Date of Event
    November 7, 2005
    Report Date
    December 2, 2005
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AFTER 2 DAYS OF SUPPORT, THE CLINICAL STAFF AT MED CTR EXPERIENCED A LOW SPEED AND LOW FLOW RATE ALARM CONDITION ON THE TANDEMHEART SYSTEM CONTROLLER AND THE TANDEMHEART PUMP STOPPED. THE STAFF ATTEMPTED TO RESTART THE PUMP, BUT WAS UNSUCCESSFUL. THE CLINICAL STAFF AT THE HOSP SWITCHED TO A BACKUP TANDEMHEART PUMP, WHICH OPERATED PROPERLY. THE PT WAS NOT ADVERSELY IMPACTED BY THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention