BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 15581849 · Received October 11, 2022

    Report

    Report Number
    9681834-2022-00197
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    September 13, 2022
    Report Date
    October 11, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. INITIAL REPORTER OCCUPATION: OCCUPATION - CLINICAL ENGINEER. PMA/510(K) - K071572, K130280. THE ACTUAL SAMPLE WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION OF THE ACTUAL SAMPLE FOUND THAT THE CROSS SECTION OF FIBER ON THE GAS CHANNEL SIDE HAD BEEN DISCOLORED IN RED. NO ANOMALY INCLUDING A BREAKAGE THAT COULD LEAD TO GAS TRANSFER FAILURE WAS FOUND. AIR WAS SUPPLIED INTO THE GAS CHANNEL OF ACTUAL SAMPLE. AS A RESULT, BUBBLY LIQUID OUTFLOW WAS FOUND. THIS LIQUID WAS CONFIRMED WITH A FACTORY-RETAINED PROTEIN TEST PAPER (URIACE) AND FOUND THAT IT CONTAINED PROTEIN. THEREFORE, THIS FLUID WAS LIKELY TO BE PLASMA. HOWEVER, IT WAS NOT POSSIBLE TO CLARIFY WHEN THIS FIBER BECAME HYDROPHILIC (AT THE TIME OF USE, AT THE TIME OF RETURN). AFTER RINSING AND DRYING THE ACTUAL SAMPLE , THE AMOUNT OF OXYGEN TRANSFER AND CARBON DIOXIDE GAS REMOVAL WERE MEASURED USING BOVINE BLOOD. IT WAS CONFIRMED TO MEET THE CONTROL STANDARD VALUES IN THE FACTORY'S SPECIFICATIONS AND NO ANOMALY WAS FOUND IN THE GAS TRANSFER PERFORMANCE. BOVINE BLOOD CONDITIONS HB: 12G/DL, TEMPERATURE: 37°C., PH: 7.4, SVO2: 65%, PVCO2: 45MMHG CIRCULATION CONDITIONS BLOOD FLOW RATE: 6L/MINUTE AND 4L/MIN, V/Q:1, FIO2: 100% O2 TRANSFER VOLUME AT 6L/MINUTE: 306ML/MINUTE, @4L/MINUTE: 204ML/MINUTE CO2 REMOVAL VOLUME AT 6L/MINUTE: 241ML/MINUTE, @4L/MINUTE: 165ML/MINUTE. REVIEW OF THE MANUFACTURING HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE CONFIRMED THAT THERE WERE NOT ANY INDICATIONS OF ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION. BASED ON THE INVESTIGATION RESULT, NO ABNORMALITY WAS FOUND IN THE GAS TRANSFER PERFORMANCE OF THE ACTUAL SAMPLE AFTER RINSING. AS A CAUSE OF OCCURRENCE OF THIS CASE, FROM THE INVESTIGATION RESULT OF ACTUAL SAMPLE AND THE INFORMATION DURING REWARMING, FOLLOWING FACTORS WERE INFERRED. HOWEVER, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. IT WAS INFERRED THAT REWARMING STIMULATED THE PATIENT'S METABOLISM. THEREFORE, THE AMOUNT OF OXYGEN SUPPLIED DID NOT CATCH UP WITH THE PATIENT'S OXYGEN CONSUMPTION, AND SVO2 AND PAO2 DECREASED. IT WAS INFERRED THAT THE FIBER WAS HYDROPHILIZED (PLASMA LEAK OCCURRED) FOR SOME REASON. DUE TO THIS, THE CONTACT BETWEEN BLOOD AND GAS WAS HINDERED, RESULTING IN A DECREASE IN GAS TRANSFER PERFORMANCE. FROM OUR PAST EXPERIENCE, AS THE CAUSE OF PLASMA LEAK IN THE ACTUAL SAMPLE, IT WAS INFERRED THAT DUE TO SOME CHANGE IN BLOOD PROPERTIES, A SUBSTANCE WITH A SURFACE-ACTIVE ACTION WAS PRODUCED, AND THE RELATIONSHIP BETWEEN THE SURFACE TENSION OF BLOOD AND GAS MAINTAINED IN THE MICROPORES ON THE FIBER SURFACE WAS BROKEN. THEREFORE, PLASMA LEAK WAS LIKELY TO OCCUR. RELEVANT IFU (INSTRUCTIONS FOR USE) REFERENCE: 1) 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. 2) 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. THIS REPORT IS FOR THE SECOND DEVICE REPORTED, FOR THE FIRST DEVICE REPORTED THAT WAS USED ON THE SAME PATIENT SEE MDR 9681834-2022-00196. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX DEVICE OXYGENATOR WAS REPLACED, DUE TO GAS TRANSFER FAILURE DURING REWARMING. HOWEVER, THE REPLACED DEVICE ALSO HAD A GAS TRANSFER FAILURE. WEANING WAS DONE. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. THE PATIENT FINAL IMPACT WAS NOT HARMED. THE EVENT OCCURRED INTRA-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390822 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 211104

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown