BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX RX OXYGENATOR W/ HARDSHELL RESERVOIR

    MDR report key: 1874375 · Received October 12, 2010

    Report

    Report Number
    1124841-2010-00161
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K062381
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT BEING RETURNED BY THE USER FACILITY; HOWEVER, TERUMO IS STILL INVESTIGATING THIS ISSUE AND WILL BE SUBMITTING A F/U REPORT WHEN MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CARDIOPULMONARY BYPASS SURGERY, THE USER FACILITY CHANGED OUT THE OXYGENATOR BECAUSE THE PT'S PO2S WERE LOW. THE PRODUCT WAS CHANGED OUT, THERE WAS AN UNK AMOUNT OF BLOOD LOSS, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX RX OXYGENATOR W/ HARDSHELL RESERVOIR BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NA MG21

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK