BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 17786642 · Received September 20, 2023

    Report

    Report Number
    9681834-2023-00183
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 19, 2023
    Report Date
    September 20, 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. A3: PATIENT SEX: 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 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: 5L/MIN AND 3L/MIN, V/Q:1, FIO2: 100%. [O2 TRANSFER VOLUME] @5L/MIN: 311ML/MIN., @3L/MIN: 206ML/MIN. [CO2 REMOVAL VOLUME] AT 5L/MIN: 242ML/MIN., AT 3L/MIN: 165ML/MIN. 2. RECORD REVIEW: 2.1 THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL PRODUCT · 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: DECEMBER 12, 2022. 2.4 CONFIRMATION OF THE PUMP RECORD. · THE OBTAINED DATA INCLUDED BLOOD GAS DATA FROM 11:00. · AT 11:13, PO2 WAS 317 MMHG AND SVO2 WAS 94%. THE CIRCULATION CONDITIONS AT THIS TIME WERE BLOOD FLOW RATE: 3.95 L/MIN, GAS FLOW RATE: 2.0 L/MIN, AND FIO2: 60%. · AT AROUND 12:23, IT WAS CONFIRMED THAT THE BLOOD FLOW WAS ZERO. AFTER THAT, AT 14:13, CIRCULATION WAS RESUMED WITH BLOOD FLOW RATE: 2.52 L/MIN. · THE RELATIONSHIP BETWEEN PAO2 AND FIO2 WAS CONFIRMED. ALTHOUGH FIO2 WAS INCREASING FROM 14:33, PAO2 DECREASED TO 183MMHG AT 14:53, AND AFTER THAT, IT WAS CONFIRMED THAT IT REMAINED AROUND 200MMHG. · THE RELATIONSHIP BETWEEN PAO2 AND SVO2 WAS CONFIRMED. IT WAS CONFIRMED THAT FROM AROUND 14:13 WHEN CIRCULATION RESUMED, SVO2 HAD DECREASED. · IT WAS INFERRED THAT DURING CIRCULATION, THE TEMPERATURE WAS LOWERED TO APPROXIMATELY 26, AND THE TEMPERATURE INCREASED FROM THE TIME CIRCULATION RESUMED (AROUND 14:13). 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 POSSIBLE CAUSE OF OCCURRENCE, IT WAS INFERRED THAT THE CONTACT BETWEEN BLOOD AND GAS MAY HAVE BEEN HINDERED BY SOME FACTOR (E.G. WET LUNG), OR PAO2 DECREASED DUE TO THE INFLUENCE OF REWARMING. HOWEVER, THE CAUSE OF THIS CASE COULD NOT BE CLARIFIED. 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 15 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 APPROXIMATELY THREE HOURS AFTER THE START OF EXTRACORPOREAL CIRCULATION, IT WAS CONFIRMED THAT THE VALUE OF PAO2 DECREASED FROM 250 TO 100. THE OXYGENATOR WAS NOT EXCHANGED, AND A MEASURE WAS TAKEN TO INCREASE FI02. THE OPERATION WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519467 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO MEDICAL CORPORATION N/A 221212

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown