BEUDAMED
    FDA Adverse Event Summary report: N

    CAPIOX SX OXYGENATOR W/ HARDSHELL RESERVOIR

    MDR report key: 2032753 · Received March 23, 2011

    Report

    Report Number
    1124841-2011-00144
    Date Received
    March 23, 2011
    Report Date
    March 7, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K993772
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVAL; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. TERUMO 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 OXYGENATOR WAS NOT ADEQUATELY SUPPLYING OXYGEN TO THE PT. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK