BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2770303 · Received October 1, 2012

    Report

    Report Number
    1828100-2012-01289
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 6, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) WALKED CUSTOMER THROUGH SERVICE SCREEN. THE CUSTOMER NOTICED THAT POWER SUPPLY II WOULD SAY "FAIL" AND "GOOD" INTERMITTENTLY. EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER RECEIVED THE FOLLOWING ERROR MESSAGE "YOU MAY NOT HAVE BATTERY BACK-UP." THE DEVICE WAS NOT CHANGED OUT, AS THE UNIT CONTINUED TO FUNCTION. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 801763

    Patients

    Seq Age Sex Outcome Treatment
    1