BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX RX25 OXYGENATOR EAST

    MDR report key: 4534403 · Received February 17, 2015

    Report

    Report Number
    1124841-2015-00052
    Event Type
    Malfunction
    Date Received
    February 17, 2015
    Date of Event
    January 28, 2015
    Report Date
    January 29, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K130333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP., THAT THE PLASTIC POUCH ON THE OXYGENATOR WAS FOUND DAMAGED OUT OF BOX. NO PATIENT INVOLVEMENT AS THIS OCCURRED OUT OF BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113857 CAPIOX RX25 OXYGENATOR EAST BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. 3CXRX25RE RK18

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK