BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2182796 · Received July 8, 2011

    Report

    Report Number
    1828100-2011-02073
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 8, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT AN ERROR MESSAGE READING "BATTERY NEEDS SERVICE" "FULL BACKUP MAY NOT BE AVAILABLE WAS DISPLAYED ON THE CENTRAL CONTROL MONITOR. THE POWER SUPPLIES INDICATED THAT THE BATTERIES WERE GOOD. THE DEVICE WAS NOT CHANGED OUT. THE USER REPORTED, THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1