BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1748069 · Received June 22, 2010

    Report

    Report Number
    1748069
    Event Type
    Malfunction
    Date Received
    June 22, 2010
    Date of Event
    March 7, 2010
    Report Date
    June 18, 2010
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    BALLOON PUMP SAID AUTOFILL FAILURE BUT HELIUM TANK WAS FULL. BALLOON PUMP WAS CHANGED OUT AND WAS WORKING FINE.HEALTH PROFESSIONAL'S IMPRESSION:THIS PUMP MALFUNCTIONED WHILE BEING USED TO SUPPORT A VERY UNSTABLE CARDIAC SURGERY PATIENT. THE PUMP WAS REPLACED EMERGENTLY. AFTER MONITORING, PATIENT DID NOT APPEAR TO SUFFER ANY DAMAGE FROM MALFUNCTIONING PUMP. PUMP WAS EVALUATED BY BIOMED AND FOUND THAT THE AUTOFILL CALIBRATION HAD DRIFTED OUT OF SPEC. MOISTURE WAS ALSO FOUND IN THE PUMP HEAD (WHICH CAN ALSO RESULT IN THIS TYPE OF FAILURE, BUT WE BELIEVE THE CALIBRATION WAS RESPONSIBLE FOR THIS EVENT). UNIT UNDERWENT PREVENTIVE MAINTENANCE INSPECTION IN JANUARY BUT THIS CHECK IS NOT PART OF THE MANUFACTURER'S TEST PROCEDURE. IT HAS NOW BEEN ADDED TO OURS. UNIT WAS RECALIBRATED AND THOROUGH OPERATION TESTING PERFORMED. UNIT IS BEING RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PUMP, INTRA-AORTIC BALLOON DSP DATASCOPE CORPORATION C100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR