BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX CUSTOM PACK

    MDR report key: 17572311 · Received August 18, 2023

    Report

    Report Number
    9681834-2023-00161
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    July 19, 2023
    Report Date
    August 18, 2023
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E3: OCCUPATION: CLINICAL ENGINEER G4: PMA/510(K) - K130520 1. INVESTIGATION OF THE ACTUAL SAMPLE: 1.1. VISUAL INSPECTION OF THE ACTUAL SAMPLE UPON RECEIPT · NO ANOMALY SUCH AS A BREAKAGE WAS FOUND. · IT WAS FOUND THAT THE CROSS SECTION OF FIBER INSIDE THE HOUSING ON THE GAS CHANNEL SIDE HAD BEEN DISCOLORED RED. 1.2. GAS WAS SWEPT INTO THE GAS CHANNEL OF ACTUAL SAMPLE · IT WAS FOUND THAT A RED TRANSPARENT LIQUID WAS FLOWING OUT FROM THE GAS OUTLET SIDE. · THE LIQUID THAT FLOWED OUT WAS CONFIRMED WITH OUR PROTEIN TEST PAPER (URIACE). AS A RESULT, PROTEIN WAS CONTAINED. IT WAS LIKELY THAT THIS LIQUID WAS PLASMA THAT HAD TURNED RED TRANSPARENT DUE TO HEMOLYSIS. 1.3. THE ACTUAL SAMPLE WAS DISASSEMBLED FOR THE VISUAL INSPECTION OF THE INTERNAL CONDITION · IT WAS FOUND THAT A PART OF THE FIBER HAD BEEN DISCOLORED. · NO ANOMALY WAS FOUND IN THE WOUND STATE OF FIBER. · NO ANOMALY SUCH AS AN OCCLUSION IN THE CHANNEL WAS FOUND IN THE HEAT EXCHANGER. 1.4. ELECTRON MICROSCOPIC INSPECTION OF THE FIBER IN EACH LAYER OF THE ACTUAL SAMPLE · NO ANOMALY WAS FOUND IN THE CONDITION OF FIBER SURFACE COMPARED TO THE CURRENT PRODUCT. · THE FIBER WAS CUT AND THE CONDITION OF INNER SURFACE WAS CONFIRMED. NO ANOMALY WAS FOUND IN THE CONDITION OF MICROPORES COMPARED TO THE CURRENT PRODUCT. IN ADDITION, IT WAS FOUND THAT PLASMA COMPONENTS LEAKED OUT FROM THE INNER SURFACE OF A PART OF FIBERS. 2. RECORD REVIEW: 2.1. THE MANUFACTURING HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE · NO ANOMALY WAS FOUND. 2.2. PAST COMPLAINT FILE · NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT# WAS FOUND. 2.3. MANUFACTURING DATE: FEBRUARY 10, 2023 3. CAUSE OF OCCURRENCE/CONCLUSION: BASED ON THE INVESTIGATION RESULT, IT WAS CONFIRMED THAT A PLASMA LEAK HAD OCCURRED IN THE ACTUAL SAMPLE. AS A POSSIBLE CAUSE OF THE PLASMA LEAK, FROM OUR PAST EXPERIENCE, THE FOLLOWING FACTOR WAS INFERRED. HOWEVER, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF PLASMA LEAK. · IT WAS INFERRED THAT ANY CHANGE IN BLOOD PROPERTIES PRODUCED A SURFACE-ACTIVE SUBSTANCE THAT DISRUPTED THE SURFACE TENSION RELATIONSHIP BETWEEN BLOOD AND GAS THAT HAD BEEN MAINTAINED IN THE MICROPORES OF THE FIBER SURFACE. AS A RESULT, PLASMA LEAK WAS LIKELY TO OCCUR. RELEVANT IFU REFERENCE: "DO NOT USE AN OXYGENATOR AND RESERVOIR THAT LEAKS.REPLACE IT WITH ANOTHER CAPIOX FX15 OXYGENATOR AND RESERVOIR." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO.(B)(4). IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT A PLASMA LEAK OCCURRED FIVE TO SIX HOURS AFTER THE START OF OPERATION. (THERE WAS SOME HEMOLYSIS ON THE WAY.) SINCE IT WAS THE FINAL STAGE OF PROCEDURE, THE OPERATION WAS COMPLETED WITHOUT REPLACING THE OXYGENATOR.THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166669 CAPIOX CUSTOM PACK OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 230210

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown