BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX15 OXYGENATOR

    MDR report key: 3820073 · Received May 20, 2014

    Report

    Report Number
    9681834-2014-00133
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 20, 2014
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS RETURNED AND EVALUATED. PERFORMANCE TESTING WAS CONDUCTED WHICH INCLUDED PRESSURE LOSS WITH NORMAL SALINE AND APPEARANCE OF THE FIBER BUNDLE. THE PRESSURE DROP OF THE ACTUAL SAMPLE WAS FOUND TO BE HIGHER THAN THAT OF NORMAL PRODUCT INDICATING THE ACTUAL SAMPLE WAS OCCLUDED. A VISUAL INSPECTION WAS DONE AND IT SHOWED THERE WAS NO RED THROMBUS ON THE OXYGENATOR MODULE. AS A RESULT, THE ACTUAL SAMPLE WAS RINSED AND DRIED AND THEN SUBJECTED TO ANOTHER PERFORMANCE TEST. THE ACTUAL SAMPLE'S PERFORMANCE WAS COMPARABLE TO THAT OF NORMAL PRODUCT INDICATING THE INCREASE IN PRESSURE WAS CAUSED BY THE PRESENCE OF PROTEIN INSIDE THE OXYGENATOR MODULE. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER NOT BEEN REPORTED PREVIOUSLY. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED AN INCREASE OF PRESSURE AFTER RECIRCULATION WAS STARTED DURING AN AORTIC VALVE REPLACEMENT. THE FOLLOWING INFORMATION WAS OBTAINED FROM THE USER FACILITY: AFTER THE VALVE REPLACEMENT, THE OXYGENATOR WAS DETACHED FROM THE PATIENT; THE PATIENT DEVELOPED AN ANASTOMOTIC LEAKAGE CAUSING THE PATIENT'S BLOOD PRESSURE TO DECREASE; PROTAMINE WAS ADMINISTERED AND THE CANNULAE WERE REPOSITIONED; RECIRCULATION WAS STARTED AND THE BLOOD OUTLET PRESSURE INCREASED TO 400MMHG IN THE FLOW VOLUME 1.5L/MIN; SUBSEQUENTLY THE OXYGENATOR WAS CHANGED OUT AND REPLACED WITH A QUADROX; AS A RESULT, THE LINE PRESSURE WENT BACK TO NORMAL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT; AND THE PATIENT IS REPORTED AS "DOING OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300333 CAPIOX FX15 OXYGENATOR BLOOD GAS OXYGENATOR DTZ TERUMO CORPORATION, ASHITAKA NA 130819

    Patients

    Seq Age Sex Outcome Treatment
    1 QUADROX OXYGENATOR (MAQUET CARDIOPULMONARY AG)