BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3231113 · Received July 12, 2013

    Report

    Report Number
    1828100-2013-00723
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. THE FIELD SERVICE REPRESENTATIVE (FSR) CHANGED THE BULB IN THE UNIVERSAL POWER SUPPLY (UPS).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, ACCORDING TO THE BIOMED WHEN THE BASE WAS CONNECTED TO ALTERNATING CURRENT (A/C), THE GREEN INDICATOR LIGHT ON THE UNIVERSAL POWER SUPPLY (UPS) DID NOT ILLUMINATE. THE DEVICE WAS NOT CHANGED OUT, AS THE PERFUSIONIST DECIDED TO USE THE BASE AS IS SINCE EVERYTHING ELSE WAS WORKING, EVEN ON BATTERY BACKUP. WHEN THE BASE WAS ON BATTERY BACKUP, THE REST OF THE LIGHTS ILLUMINATED AND THE BATTERY BACK UP WORKED FINE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND 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
    324790 TERUMO PERFUSION SYSTEM 8000 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16401

    Patients

    Seq Age Sex Outcome Treatment
    1