BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPIOX RX25 OXYGENATOR EAST

    MDR report key: 4478018 · Received January 30, 2015

    Report

    Report Number
    1124841-2015-00039
    Event Type
    Death
    Date Received
    January 30, 2015
    Date of Event
    January 21, 2015
    Report Date
    January 21, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K130333
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP THAT WHEN ATTEMPTING TO PRIME THE PUMP FOR AN EMERGENCY CASE, A SPECIMEN OF FOREIGN MATTER WAS OBSERVED IN THE RESERVOIR. THE USER DECIDED TO CHANGE OUT THE CIRCUIT, WHICH TOOK TEN MINUTES. IT WAS THEN DECIDED TO PUT THE PT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND NOT TO DO BYPASS. THE DECISION TO NOT PERFORM THE SURGERY WAS NOT DUE TO THE ISSUE OF FOREIGN MATTER FOUND IN THE RESERVOIR. THE CIRCUIT WAS NOT USED. THE PT EXPIRED WHILE ON ECMO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72367 CAPIOX RX25 OXYGENATOR EAST DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. 3CX*RX25RE RK20

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death