BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX CUSTOM PACK

    MDR report key: 17395593 · Received July 26, 2023

    Report

    Report Number
    9681834-2023-00146
    Event Type
    Malfunction
    Date Received
    July 26, 2023
    Date of Event
    June 27, 2023
    Report Date
    July 26, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    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

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D4: UDI NO: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: CLINICAL ENGINEER. G4: 510(K) NO: K071494, 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. 1.2. AFTER RINSING AND DRYING THE ACTUAL SAMPLE, THE AMOUNT OF OXYGEN TRANSFER AND CARBON DIOXIDE GAS REMOVAL WERE MEASURED ACCORDING TO THE PRODUCT INSPECTION PROCEDURE IT WAS CONFIRMED TO MEET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND [BOVINE BLOOD CONDITIONS] HB: 12G/DL, TEMP.: 37°C., PH: 7.4, SVO2: 65%, PVCO2: 45MMHG [CIRCULATION CONDITIONS] BLOOD FLOW RATE: 6L/MIN AND 4L/MIN, V/Q:1, FIO2: 100% [O2 TRANSFER VOLUME] @6L/MIN: 389ML/MIN., @4L/MIN: 279ML/MIN [CO2 REMOVAL VOLUME] @6L/MIN: 319ML/MIN., @4L/MIN: 229ML/MIN 2. RECORD REVIEW: 2.1. THE MANUFACTURING 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: MARCH 13, 2023 2.4. CONFIRMATION OF THE PUMP RECORD · THE PATIENT'S HEIGHT: 162CM, WEIGHT: 72KG, AND BSA: 1.77M2. · AFTER STARTING EXTRACORPOREAL CIRCULATION, PAO2 REMAINED AT APPROXIMATELY 200MMHG. THE CIRCULATION CONDITIONS AT THIS TIME WERE A FLOW RATE OF APPROXIMATELY 4L/MIN AND FIO2 OF 0.5. · CIRCULATION STOPPED FOR APPROXIMATELY 1 HOUR FROM 2 HOURS AFTER THE START OF CIRCULATION. AFTER RESUMING CIRCULATION, PAO2 HAD DROPPED TO 146MMHG. AFTER THAT, FIO2 WAS GRADUALLY INCREASED, BUT PAO2 TENDED TO DECREASE EVEN WHEN FIO2 WAS INCREASED TO 1. · THE RELATIONSHIP BETWEEN PAO2 AND SVO2 WAS CONFIRMED. SVO2 TRENDED DECREASED FROM THE TIME PAO2 DECREASED AFTER CIRCULATION WAS RESUMED. · THE RELATIONSHIP BETWEEN SVO2 AND RECTAL TEMPERATURE WAS CONFIRMED. FROM THE TIME SVO2 DECREASED, THE RECTAL TEMPERATURE INCREASED. THERE WAS A DESCRIPTION OF "WARMING" IN THE EVENT FIELD, AND THE REWARMING HAD STARTED. 3. CAUSE OF OCCURRENCE/CONCLUSION: BASED ON THE INVESTIGATION RESULT, THE GAS TRANSFER PERFORMANCE OF ACTUAL SAMPLE AFTER RINSING MET THE FACTORY'S SPECIFICATIONS, AND NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS. AS A POSSIBLE CAUSE OF OCCURRENCE, FOLLOWING FACTORS WERE INFERRED. HOWEVER, SINCE NO ANOMALY WAS FOUND IN THE ACTUAL SAMPLE AFTER RINSING, THE CAUSE OF THIS CASE COULD NOT BE CLARIFIED. [BEFORE CIRCULATION STOPPED] · IT WAS INFERRED THAT FOR FIO2 AT THE TIME OF USE, THE OXYGEN SUPPLY AMOUNT WAS INSUFFICIENT FOR THE PATIENT'S METABOLISM. [AFTER CIRCULATION RESUMED] · IT WAS INFERRED THAT DUE TO REWARMING, THE OXYGENATION DID NOT KEEP UP WITH THE INCREASE IN THE PATIENT'S OXYGEN CONSUMPTION. THEREFORE, THE DECREASE IN SVO2 HAD AN EFFECT. · THE CONTACT BETWEEN BLOOD AND GAS MAY HAVE BEEN HINDERED BY SOME FACTOR (E.G. WET LUNG). RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "START GAS SUPPLY WITH V/Q=1, AND FIO2=100%, THEN MAKE ADJUSTMENTS BASED ON BLOOD GAS MEASUREMENTS. MEASURE BLOOD GASES AND MAKE NECESSARY ADJUSTMENTS AS FOLLOWS. A.CONTROL PAO2 BY CHANGING CONCENTRATION OF OXYGEN IN VENTILATING GAS USING GAS BLENDER. TO DECREASE PAO2, DECREASE[?]FIO2. TO INCREASE PAO2, INCREASE FIO2. B.CONTROL PACO2 BY CHANGING THE TOTAL GAS FLOW. TO DECREASE PACO2, INCREASE TOTAL GAS FLOW. TO INCREASE PACO2, DECREASE TOTAL GAS FLOW. A PHENOMENON CALLED WET LUNG MAY OCCUR WHEN WATER CONDENSATION OCCURS INSIDE FIBERS OF MICROPOROUS MEMBRANE OXYGENATORS WITH BLOOD FLOWING EXTERIOR TO THE FIBERS. THIS MAY OCCUR WHEN OXYGENATORS ARE USED FOR A LONGER PERIOD OF TIME. IF WATER CONDENSATION AND/OR A DECREASE IN PAO2 AND/OR AN INCREASE IN PACO2 IS NOTED DURING EXTENDED OXYGENATOR USE, BRIEFLY INCREASING THE GAS FLOW RATE MAY IMPROVE THE PERFORMANCE. INCREASE GAS FLOW RATE, TO 20 L/MIN FOR 10 SECONDS. DO NOT REPEAT THIS FLUSHING TECHNIQUE, EVEN IF OXYGENATOR PERFORMANCE IS NOT IMPROVED. UPON PATIENT REWARMING, ADJUST O2 CONCENTRATION, GAS FLOW RATE AND BLOOD FLOW RATE BY INCREASING THEM AS NEEDED BASED ON AN INCREASE IN PATIENTS METABOLISM. FAILURE TO ADJUST THE GAS SUPPLY AND THE BLOOD FLOW RATE APPROPRIATELY MAY CAUSE INSUFFICIENT O2 SUPPLY NEEDED OR THE AMOUNT OF THE PATIENT'S GASEOUS METABOLISM." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING EXTRACORPOREAL CIRCULATION, OXYGENATION WAS ALWAYS POOR. THE PRODUCT WAS USED AS IT WAS, BUT AFTER 6 HOURS FROM THE START OF USE, FX15 WAS ADDED TO THE VENOUS LINE FOR OXYGENATION. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840415 CAPIOX CUSTOM PACK OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO MEDICAL CORPORATION N/A 230313

    Patients

    Seq Age Sex Outcome Treatment
    1 Male