BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1350652 · Received February 13, 2009

    Report

    Report Number
    1828100-2009-00077
    Event Type
    Malfunction
    Date Received
    February 13, 2009
    Date of Event
    January 8, 2009
    Report Date
    February 13, 2009
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    KRL
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    WHEN IN USE, THE AIR BUBBLE DETECTOR OF A HEART LUNG CONSOLE PRODUCED FALSE ALARM. THERE WERE NO REPORTED CONSEQUENCES TO THE PT 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 (AIR BUBBLE SENSOR) KRL TERUMO CARDIOVASCULAR SYSTEMS CORP 802110

    Patients

    Seq Age Sex Outcome Treatment
    1