BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX OXYGENATOR

    MDR report key: 19629684 · Received June 27, 2024

    Report

    Report Number
    9681834-2024-00103
    Event Type
    Malfunction
    Date Received
    June 27, 2024
    Date of Event
    May 29, 2024
    Report Date
    June 27, 2024
    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. 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. VISUAL INSPECTION OF THE ACTUAL SAMPLE UPON RECEIPT - NO ANOMALY SUCH AS A BREAKAGE WAS FOUND. 2. THE ACTUAL SAMPLE, AFTER RINSED AND DRIED, WAS TESTED FOR THE O2 TRANSFER AND CO2 REMOVAL PERFORMANCE IN ACCORDANCE WITH THE PRODUCT INSPECTION PROTOCOL. THE MEASURED VALUES WERE 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: 45 MMHG [CIRCULATION CONDITIONS] BLOOD FLOW RATE: 6 L/MIN AND 4 L/MIN, V/Q:1, FIO2: 100% [O2 TRANSFER VOLUME] 6L/MIN: 374ML/MIN., 4L/MIN: 271ML/MIN [CO2 REMOVAL VOLUME] @6L/MIN: 295 ML/MIN., @4L/MIN: 227 ML/MIN 3. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE - NO ANOMALY WAS FOUND. 4. PAST COMPLAINT FILE OF THE INVOLVED PRODUCT CODE AND LOT NUMBER - NO OTHER SIMILAR REPORT WAS FOUND 5. MANUFACTURING DATE: JANUARY 23, 2024 6. CAUSE OF OCCURRENCE/CONCLUSION BASED ON THE INVESTIGATION RESULT, THE GAS TRANSFER PERFORMANCE OF THE ACTUAL SAMPLE AFTER RINSING MET THE FACTORY'S SPECIFICATIONS, AND NO ANOMALY WAS FOUND. AS A POSSIBLE CAUSE OF OCCURRENCE, BASED ON OUR PAST EXPERIENCE, PACO2 WAS LIKELY TO HAVE INCREASED DUE TO THE FOLLOWING FACTORS. HOWEVER, THE CAUSE OF THIS CASE COULD NOT BE CLARIFIED FROM THE INVESTIGATION RESULT. - DUE TO THE EFFECT OF CO2 INSUFFLATED INTO THE SURGICAL FIELD, PCO2 OF THE BLOOD ASPIRATED FROM THORACIC CAVITY INCREASED, AND THE PCO2 OF THE BLOOD FLOWING INTO THE OXYGENATOR INCREASED. 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.". 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 THE PCO2 VALUE BECAME ABNORMALLY HIGH. SINCE THIS WAS FOUND BEFORE DE-CLAMPING, THE PRODUCT IN QUESTION WAS NOT CHANGED OUT AND THE SURGERY WAS COMPLETED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786816 CAPIOX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO MEDICAL CORPORATION N/A 240123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown