BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 19834508 · Received July 25, 2024

    Report

    Report Number
    9681834-2024-00125
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    June 27, 2024
    Report Date
    July 25, 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

    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 . D4: UDI: 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: 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 ANOMALIES WERE 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: 411 ML/MIN., @4L/MIN: 291 L/MIN. [CO2 REMOVAL VOLUME] @6L/MIN: 336 ML/MIN., @4L/MIN: 243 ML/MIN. 3. REVIEW OF THE PUMP RECORD. - AFTER THE START OF EXTRACORPOREAL CIRCULATION (12:20), THE FIRST MEASURED PAO2 WAS 329 MMHG. THE CIRCULATION CONDITIONS AT THIS TIME WERE AS FOLLOWS: BLOOD FLOW RATE: 3.6 L/MIN, GAS FLOW RATE: 1.1 L/MIN, AND FIO2: 60%. - AT 16:06, IT WAS NOTED THAT PAO2 HAD DECREASED TO 97.6 MMHG. - REGARDING THE RELATIONSHIP BETWEEN PAO2 AND SO2, IT WAS FOUND THAT FROM 13:30 ONWARDS, SO2 REMAINED AT APPROXIMATELY 90 %. HOWEVER, AROUND 15:25, SO2 STARTED TO DECLINE, AND BY 16:06, WHEN PAO2 HAD DROPPED TO 97.6 MMHG, SO2 HAD DECREASED TO 68%. - REGARDING THE RELATIONSHIP BETWEEN SO2 AND ARTERIAL BLOOD TEMPERATURE, IT WAS NOTED THAT THE TEMPERATURE BEGAN TO RISE FROM AROUND 15:25, COINCIDING WITH THE DECREASE IN SO2. THIS SUGGESTS THAT REWARMING HAD INITIATED AT THAT TIME. 4. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE NO ANOMALY WAS FOUND IN THEM. 5. PAST COMPLAINT FILE OF THE INVOLVED PRODUCT CODE AND LOT NUMBER NO OTHER SIMILAR REPORT WAS FOUND. 6. MANUFACTURING DATE: JANUARY 31, 2024. 7. CAUSE OF OCCURRENCE/CONCLUSION BASED ON THE INVESTIGATION RESULTS, IT WAS DETERMINED THAT THE GAS EXCHANGE PERFORMANCE OF THE ACTUAL SAMPLE AFTER CLEANING MET THE FACTORY'S SPECIFICATIONS, AND NO ANOMALIES WERE FOUND. THE FOLLOWING FACTORS WERE ASSUMED TO HAVE OVERLAPPED LEADING TO THE REPORTED EVENT; HOWEVER, THE DEFINITE CAUSE COULD NOT BE DETERMINED FROM THE CONDITION OF THE ACTUAL SAMPLE. - IT WAS INFERRED THAT THE CONTACT BETWEEN THE BLOOD AND GAS WAS PREVENTED DUE TO SOME FACTORS (E.G., WET LUNG), THEREFORE, EVEN THOUGH FIO2 WAS INCREASED, PAO2 DID NOT INCREASE, RESULTING IN POOR OXYGENATION. - IT WAS INFERRED THAT REWARMING STIMULATED THE PATIENT'S METABOLISM, WHICH INCREASED OXYGEN CONSUMPTION, CAUSING A DECREASE IN SVO2 AND A DECREASE IN PAO2. 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, DECREASEFIO2. -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 THOUGH FIO2 WAS 100% AND THE FLOW RATE WAS 3.5L, PAO2 WAS ONLY AROUND 150 AND CONTINUED TO DECREASE. WHEN IT FELL BELOW 100, THE OXYGENATOR WAS REPLACED. JUDGED AS SERIOUS INJURY DUE TO THE OXYGENATOR HAVING BEEN CHANGED OUT THOUGH THERE WAS NO HEALTH HAZARD ATTRIBUTABLE TO THE EVENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946210 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 240131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other