BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX RX25 OXYGENATOR WEST

    MDR report key: 3862386 · Received April 25, 2014

    Report

    Report Number
    1124841-2014-00056
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 2, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K130333
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    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 INFO BECOMES AVAILABLE. (B)(4). CONCLUSION CODE: CONCLUSION NOT YET AVAILABLE - EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORPORATION THAT DURING CARDIOPULMONARY BYPASS AIR WAS NOTED IN THE ARTERIAL CIRCULATION OF THE CIRCUIT. THE PT HAD BEEN PLACED BACK ON BYPASS DURING CABG DUE TO A SUDDEN CHANGE IN CARDIAC STATUS. SHORTLY AFTER BYPASS WAS INITIATED, AIR WAS NOTED IN THE ARTERIAL CIRCUIT. THE SOURCE OF THE AIR WAS UNK. BYPASS WAS STOPPED AND ATTEMPTS WERE MADE TO EVACUATE THE AIR. BYPASS WAS THEN RE-INITIATED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PT REMOVED FROM BYPASS. POST-OP, THE PT WAS UNABLE TO RESPOND TO COMMANDS AND HAD NO PURPOSEFUL MOVEMENTS. OUTSIDE LEGAL COUNSEL FROM THE HOSPITAL INFORMED TERUMO CLINICAL SPECIALIST (ON (B)(6) /2014) THAT THE PT HAD BEEN DISCHARGED FROM THE HOSPITAL AND WAS IN A LONG TERM CARE FACILITY. REF UF REPORT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250491 CAPIOX RX25 OXYGENATOR WEST BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. 3ZZRX25RW QM21

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention