BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX SX OXYGENATORS

    MDR report key: 2181035 · Received July 1, 2011

    Report

    Report Number
    1828100-2011-01817
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 1, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K961000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 THE SCREW THAT ATTACHES THE CAPIOX HOLDER TO THE POLE WAS STRIPPED. 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 CAPIOX SX OXYGENATORS HOLDER FOR CAPIOX DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801804

    Patients

    Seq Age Sex Outcome Treatment
    1