BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 19768344 · Received July 17, 2024

    Report

    Report Number
    9681834-2024-00098
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    June 17, 2024
    Report Date
    July 17, 2024
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP 1 TO CORRECT SECTION D3.

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3A: SEX: REQUESTED, NOT PROVIDED. A3B: GENDER: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 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. 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 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: 371ML/MIN., @4L/MIN: 267ML/MIN. [CO2 REMOVAL VOLUME] @6L/MIN: 321ML/MIN., @4L/MIN: 235ML/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: OCTOBER 23, 2023. 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. AS A CAUSE OF OCCURRENCE, FOLLOWING FACTORS THAT MAY HAVE CAUSED A DECREASE IN PAO2 WERE INFERRED BASED ON OUR PAST EXPERIENCE. HOWEVER, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF THIS CASE FROM THE INVESTIGATION RESULT. SINCE THE BLOOD CLOT WAS FORMED, THE CONTACT BETWEEN BLOOD AND OXYGEN GAS WAS HINDERED, AND THE GAS TRANSFER PERFORMANCE WAS DECREASED. SINCE PLASMA LEAKAGE OCCURRED, THE CONTACT BETWEEN BLOOD AND OXYGEN GAS WAS HINDERED, AND THE GAS TRANSFER PERFORMANCE WAS DECREASED. DUE TO WET LUNG PHENOMENON, WATER DROPS ACCUMULATED IN THE FIBER. THEREFORE, THE CONTACT BETWEEN BLOOD AND OXYGEN GAS WAS HINDERED, AND THE GAS TRANSFER PERFORMANCE WAS DECREASED. AS THE PATIENT WAS REWARMED, PATIENT'S OXYGEN TRANSPORT WAS NOT KEEPING UP WITH THE INCREASE IN OXYGEN CONSUMPTION, CAUSING SVO2 TO DECREASE AND THEN PO2 TO DECREASE. RELEVANT 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 20L/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 APPROXIMATELY THREE HOURS AFTER THE PUMP WAS TURNED ON, PO2 VALUE DECREASED. EVEN SETTING FIO2 TO 100%, THE CONDITION DID NOT IMPROVE. THE ACTUAL PRODUCT WAS REPLACED AND THE OPERATION WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362651 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 231023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other