BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 4297433 · Received November 26, 2014

    Report

    Report Number
    1828100-2014-01017
    Event Type
    Malfunction
    Date Received
    November 26, 2014
    Date of Event
    November 4, 2014
    Report Date
    November 5, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWB
    PMA / PMN Number
    K953901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REP (FSR) WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE ROLLER PUMP WAS TURNED ON AND OFF REPEATEDLY WITHOUT ANY ERROR MESSAGE AND "FWD" MODE WORKED AS INTENDED. CORRECTIVE MAINTENANCE/INSPECTION WAS COMPLETED. THE UNIT OPERATED TO MFR SPECS AND WAS RETURNED TO CLINICAL USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, A "FALL 5" ERROR MESSAGE WAS DISPLAYED ON THE ROLLER PUMP AND "FWD" MODE DOES NOT WORK. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769231 TERUMO PERFUSION SYSTEM 8000 8K (PUMP, ROLLER TYPE) DWB TERUMO CARDIOVASCULAR SYSTEMS CORP. 16402

    Patients

    Seq Age Sex Outcome Treatment
    1