BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 19666371 · Received July 3, 2024

    Report

    Report Number
    9681834-2024-00110
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 5, 2024
    Report Date
    July 3, 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: N/A. 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: 510(K) NUMBER: K130520. 1. SINCE THE ACTUAL SAMPLE WAS USED FOR AN HCV-POSITIVE PATIENT, DETAILED ANALYSIS OF IT WAS NOT POSSIBLE, AND ONLY THE APPEARANCE WAS CONFIRMED. VISUAL INSPECTION OF THE ACTUAL SAMPLE UPON RECEIPT FOUND NO BREAKAGE. 2. REVIEW OF THE MANUFACTURING RECORD AND SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE - NO ANOMALY WAS FOUND IN THEM. 3. PAST COMPLAINT FILE OF THE INVOLVED PRODUCT CODE AND LOT NUMBER - NO OTHER SIMILAR REPORT WAS FOUND. 4. CAUSE OF OCCURRENCE/CONCLUSION. ACCORDING TO THE INVESTIGATION RESULTS, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS; HOWEVER, CLOSE INVESTIGATION OF THE ACTUAL SAMPLE COULD NOT BE PERFORMED, THE CAUSE OF THE OCCURRENCE OF THE REPORTED EVENT 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. UPON PATIENT REWARMING, ADJUST O2 CONCENTRATION, GAS FLOW RATE AND BLOOD FLOW RATE BY INCREASING THEM AS NEEDED BASED ON AN INCREASING 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. 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." 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 DEVICE WAS USED FOR A NORMAL ECC. OXYGENATION PERFORMANCE DECREASED. THE PRODUCT IN QUESTION WAS EXCHANGED AND THE PROCEDURE WAS CONTINUED. SERIOUS INJURY AS THE OXYGENATOR IN QUESTION WAS CHANGED OUT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759370 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 240214

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other