BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX RX25 OXYGENATOR EAST

    MDR report key: 2971725 · Received January 30, 2013

    Report

    Report Number
    1124841-2013-00025
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 15, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K062381
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETED AND MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CARDIOPULMONARY BYPASS SURGERY, TO PLACE BIVENTRICULAR ASSIST DEVICES TO SUPPORT POOR CARDIAC FUNCTION, THE PT WAS VERY COMPROMISED WITH LOW PARTIAL PRESSURE OF OXYGEN IN ARTERIAL BLOOD (PAO2), LOW MIXED VENOUS OXYGEN SATURATION (SVO2), AND WAS HYPOTENSIVE. THE PROCEDURE WAS COMPLETED, AS SCHEDULED, BUT THE PT EXPIRED POST PROCEDURE DUE TO MYOCARDIAL FUNCTION ISSUES. PRODUCT WAS NOT CHANGED OUT. SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41824 CAPIOX RX25 OXYGENATOR EAST BLOOD-GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. 3CX*RX25RE PH16

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death