BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-COATED CAPIOX SX W/HARDSHELL RESERVOIR

    MDR report key: 2945212 · Received January 31, 2013

    Report

    Report Number
    1124841-2013-00029
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTZ
    PMA / PMN Number
    K993772
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO CARDIOVASCULAR SYSTEMS DID NOT RECEIVE THE ACTUAL DEVICE; HOWEVER, AN INVESTIGATION WAS CONDUCTED ON A RETENTION SAMPLE (3CXSXRX, LOT PM15) AND NO ISSUES WERE NOTED, THUS THE COMPLAINT WAS NOT CONFIRMED. BECAUSE THE UNITS ARE 100% LEAK TESTED, 100% VISION INSPECTED, AND 100% CHECKED BY A VISION SYSTEM FOR THE PRESENCE OF ALL CAPS, TERUMO CONCLUDED THAT IT IS HIGHLY LIKELY THAT THE ACTUAL DEVICE WAS DAMAGED POST MANUFACTURING. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING SETUP, THE LUER PORT ON TOP OF THE RESERVOIR WAS BROKEN. THERE WAS NO PT INVOLVEMENT AS THIS OCCURRED DURING SETUP. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42284 X-COATED CAPIOX SX W/HARDSHELL RESERVOIR BLOOD-GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEM CORP NA PL17

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK