BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR W/O RESERVOIR

    MDR report key: 2840168 · Received November 13, 2012

    Report

    Report Number
    9681834-2012-00073
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 26, 2012
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT REC'D THE ACTUAL DEVICE FOR EVAL; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CARDIOPULMONARY BYPASS SURGERY, A CLOT WAS IN THE OXYGENATOR. ROBERT RICE CLINICAL SPECIALIST SPOKE TO GILL GURINDER CCP ON (B)(6) 2012. THE PROCEDURE WAS A CABG. AFTER 90-100 MINS INTO CARDIOPULMONARY BYPASS (CPB) A CLOT WAS OBSERVED IN THE FX25RE OXYGENATOR. THE ACTIVATED CLOTTING TIME (ACT) WAS GREATER THAN 500 SECONDS. HE FELT THE FIO2S NEEDED TO BE HIGHER THAN USUAL TO ATTAIN SIMILAR OXYGEN TRANSFER LEVELS AND THE CIRCUIT LINE PRESSURE WAS ABOUT 30 MMHG HIGHER THAN EXPECTED. THE OXYGENATOR WAS NOT CHANGED OUT AND THE PT WAS WEANED FROM CPB W/O ISSUE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY IN THE PROCEDURE AND THERE WAS NO BLOOD LOSS ASSOCIATED WITH THIS EVENT. THE PT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) PER ROUTINE PRACTICE AND NO HARM WAS OBSERVED. THE PT WAS AWAKE AND ALERT A FEW HRS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX FX OXYGENATOR W/O RESERVOIR BLOOD-GAS OXYGENATOR DTZ TERUMO CORPORATION, ASHITAKA ZZ*FX25REA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR