BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM I

    MDR report key: 2201099 · Received July 29, 2011

    Report

    Report Number
    1828100-2011-02320
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 29, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE LATCH THAT CLAMPS DOWN TO HOLD THE TUBING IN WAS LOOSE AND DIDN'T CLAMP DOWN TIGHT ENOUGH. THE DEVICE WAS NOT CHANGED OUT. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE 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 I FLOW SENSOR DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 6382

    Patients

    Seq Age Sex Outcome Treatment
    1