BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX RX05

    MDR report key: 3893423 · Received June 25, 2014

    Report

    Report Number
    9681834-2014-00172
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 25, 2014
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K022115
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH AN ESTIMATED VOLUME IS NOT AVAILABLE, THE REPORTED INFORMATION INDICATES THAT THE PEDIATRIC PATIENT EXPERIENCED BLOOD LOSS AS A RESULT OF THE OXYGENATOR CHANGE OUT. THIS SECTION WAS COMPLETED BY THE MANUFACTURER PER CFR 803.52(F) (11) BECAUSE THE INFORMATION WAS NOT INITIALLY COMPLETED BY THE USER FACILITY. (B)(4). ALTHOUGH THERE WAS REPORTEDLY NO IMPACT TO THE PATIENT AND AN ESTIMATED VOLUME WAS NOT AVAILABLE, THE EVENT DESCRIPTION INDICATES THAT SOME BLOOD LOSS DID OCCUR DURING THE CHANGE OUT OF THE DEVICE. THE ACTUAL SAMPLE WAS RETURNED AND EVALUATED. VISUAL INSPECTION CONFIRMED THAT THERE WERE NO ANOMALIES IN APPEARANCE. THE DEVICE WAS PERFORMANCE TESTED BY BEING ATTACHED TO A CIRCUIT WITH TUBES AND 1L OF SALINE SOLUTION WAS CIRCULATED THROUGH THE DEVICE. THE PRESSURE DROP OF THE ACTUAL SAMPLE WAS FOUND TO EXCEED 300MMHG WHEN THE CIRCULATION FLOW RATE REACHED 0.28L/MIN. VISUAL INSPECTION SHOWED, THROUGH MAGNIFYING INSPECTION AND ELECTRON MICROSCOPY, THE GENERATION OF FIBRIN NET, ECHINOCYTE OF RED BLOOD CELLS AND PLATELET AGGREGATION WHERE THE THROMBUS HAD FORMED. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN PREVIOUSLY REPORTED. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THIS LOT NUMBER. ALTHOUGH THE CAUSE FOR THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THERE ARE MANY COMPLEX CLINICAL VARIABLES THAT MAY HAVE AFFECTED THE DESCRIBED CONDITIONS DURING THE PROCEDURE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT ABOUT 20 MINUTES AFTER THE EXTRACORPORAL CIRCULATION (ECC) WAS STARTED, THE PRESSURE IN THE INLET PORT OF THE OXYGENATOR INCREASED AND THAT OXYGENATION DECREASED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: (1) THE EVENT OCCURRED DURING A FONTAN PROCEDURE ON A PEDIATRIC PATIENT; (2) WHEN THE PRESSURE INCREASED/OXYGEN LEVEL DECREASED, THE PROCEDURE WAS STOPPED AND THE DEVICE WAS CHANGED OUT FOR A NEW CAPIOX RX05; (3) THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND (4) REPORTEDLY THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370975 CAPIOX RX05 BLOOD GAS OXYGENATOR DTZ TERUMO CORPORATION, ASHITAKA NA 140218

    Patients

    Seq Age Sex Outcome Treatment
    1 Other