BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 8077106 · Received November 16, 2018

    Report

    Report Number
    9681834-2018-00204
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    October 31, 2018
    Report Date
    November 16, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510(K) NO: K130280 THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION UPON RECEIPT REVEALED NO ANOMALY, SUCH AS A BREAK, IN THE APPEARANCE. THE ACTUAL DEVICE WAS FIXED WITH GLUTARALDEHYDE SOLUTION. THE HOUSING AND FILTER WERE REMOVED FROM THE OXYGENATOR MODULE. VISUAL INSPECTION OF THE FILTER DID NOT REVEAL ANY CLOT FORMATION VISIBLE TO THE UNAIDED EYE EITHER ON THE OUTER OR INNER SURFACE. VISUAL INSPECTION OF THE OXYGENATOR MODULE, AFTER THE HOUSING AND FILTER HAVING BEEN REMOVED FROM IT, DID NOT REVEAL ANY COT FORMATION VISIBLE TO THE UNAIDED EYE ON THE FIBER. THE FIBER WINDING WAS CONFIRMED TO BE IN THE NORMAL STATE. THE FIBER LAYER WAS REMOVED FROM THE WINDING IN INCREMENTS OF 2MM AND EACH LAYER WAS SUBJECTED TO VISUAL INSPECTION. SOME CLOTS WERE FOUND TO HAVE FORMED ON THE FIBER LAYERS LOCATED CLOSE TO THE HEAT EXCHANGER MODULE. THE FIBER AND THE OUTER CYLINDER WERE REMOVED FROM THE HEAT EXCHANGER MODULE AND THE INSIDE OF THE HEAT EXCHANGER MODULE WAS SUBJECTED TO VISUAL AND MAGNIFYING INSPECTIONS. NO CLOT FORMATION WAS CONFIRMED. THE FILTER REMOVED FROM THE OXYGENATOR MODULE IN THE ABOVE INSPECTION WAS INSPECTED UNDER MAGNIFICATION AND REVEALED NO CLOT FORMATION. THE DIAMETER OF THE MESH OF THE FILTER WAS CONFIRMED TO BE NORMAL. THE FIBER LAYERS REMOVED DURING THE ABOVE TEST WERE INSPECTED UNDER MAGNIFICATION. SOME CLOTS WERE FOUND TO HAVE FORMED ON THE FIBER LAYERS LOCATED ON 8MM FROM THE OUTMOST CIRCUMFERENCE TO THE LAST LAYER ON THE HEAT EXCHANGER. THE FILTER WAS INSPECTED UNDER ELECTRON MICROSCOPE. THE ADHESION OF THE ERYTHROCYTE COMPONENTS, INCLUDING PLATELETS, WERE FOUND ON THE SURFACE. ELECTRON MICROSCOPIC INSPECTION OF THE FIBER ON EACH LAYER ON THE UPPER SIDE OF THE FIBER WINDING OBTAINED IN ABOVE INSPECTION REVEALED NO CLOT FORMATION WHICH COULD HAVE CONTRIBUTED TO THE PRESSURE RISE. A REVIEW OF THE DEVICE HISTORY RECORD OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION REVEALED NO FINDINGS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. DURING THE INSPECTION OF THE ACTUAL DEVICE, SOME PLATELETS WERE FOUND TO BE ADHERING TO THE OXYGENATOR MODULE. HOWEVER, IT CANNOT BE DETERMINED IF THIS HAS ANY CAUSE-AND-EFFECT RELATIONSHIP WITH THE REPORTED COMPLAINT. THE IFU STATES: "DO NOT REDUCE HEPARIN DURING CIRCULATION. OTHERWISE, BLOOD CLOTTING MIGHT OCCUR. ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED TO PREVENT IT FROM CLOTTING IN THE SYSTEM." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT SOON AFTER THE INITIATION OF THE EXTRACORPOREAL CIRCULATION, THERE WAS A RISE IN THE PRESSURE BEFORE THE MEMBRANE WAS NOTED WHEN USING THE INVOLVED CAPIOX DEVICE. THE PRESSURE WENT UP HIGHER THAN THE ALARMING VALUE OF 500 MMHG. THE ACTUAL SAMPLE WAS CHANGED OUT. BLOOD LOSS WAS REPORTED TO BE 43 ML. THE PROCEDURE OUTCOME IS UNKNOWN. THE FINAL PATIENT IMPACT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920653 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 180702

    Patients

    Seq Age Sex Outcome Treatment
    1 Other