BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2915437 · Received January 9, 2013

    Report

    Report Number
    1828100-2013-00048
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 13, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED SCRAP PIECES OF METAL CAME FROM THE FIXED PARTS (DISPLAY MOUNTING BRACKET ASSEMBLY). THE UNIT WAS CHANGED OUT AFTER THE CASE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12721 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP 801441

    Patients

    Seq Age Sex Outcome Treatment
    1