BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 4172382 · Received October 9, 2014

    Report

    Report Number
    1828100-2014-00839
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED. THE USER FACILITY BIOMED STATED THAT THE UNIT MAY NOT HAVE BEEN CHARGED PROPERLY. THE FIELD SVC REP (FSR) NOTED THAT BATTERIES ARE TO BE CHANGED EVERY TWO YEARS. THE LAST RECORD BATTERIES WERE CHANGED WAS IN (B)(4) 2011. THE BATTERIES SHOULD HAVE BEEN REPLACED IN (B)(4) 2013. BATTERIES VOLTAGE MEASURED 25VDC TOTAL FOR BOTH, BUT WOULD NOT WORK WHEN A LOAD WAS APPLIED. THE FSR REPLACED BATTERIES AND PERFORMED PREVENTIVE MAINTENANCE (PM). THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS 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, THE PERFUSIONIST NOTICED THE GREEN CHARING LIGHT WAS NOT ILLUMINATED. WHEN THE MACHINE WAS UNPLUGGED, IT DID NOT GO ON BATTERY. AS A RESULT, AN ALTERNATE SYSTEM WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636808 TERUMO PERFUSION SYSTEM 8000 8K DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16401

    Patients

    Seq Age Sex Outcome Treatment
    1