BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3162438 · Received June 6, 2013

    Report

    Report Number
    1828100-2013-00553
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. THE FIELD SERVICE REP (FSR) WAS UNABLE TO DUPLICATE THE ISSUE. AS A PRECAUTIONARY MEASURE, THE FSR CHANGED OUT THE TEMPERATURE MODULE, TESTED THE UNIT TO MFR'S SPECS AND RETURNED THE UNIT TO CLINICAL USE. THE FSR RETURNED SOFTWARE LOGS AND TEMPERATURE MODULE TO THE MFR FOR FURTHER EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE TEMPERATURE READINGS WERE TOO HIGH. THE DEVICE WAS NOT CHANGED OUT, AS TWO OTHER TEMPERATURE MODULES WERE AVAILABLE FOR READINGS. 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
    251453 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802114

    Patients

    Seq Age Sex Outcome Treatment
    1