BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX SX OXYGENATOR

    MDR report key: 2852648 · Received November 27, 2012

    Report

    Report Number
    1124841-2012-00120
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTN
    PMA / PMN Number
    K002238
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION. TERUMO PLANS ON SUBMITTING A F/U REPORT WHEN THE INVESTIGATION IS COMPLETED AND MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THE OXYGEN WAS LEAKING FLUID FROM THE GAS OUT PORT. PRODUCT WAS CHANGED OUT. SURGERY WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX SX OXYGENATOR BLOOD-GAS OXYGENATOR DTN TERUMO CARDIOVASCULAR SYSTEMS CORP. NA PK27

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK