BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX05

    MDR report key: 17395584 · Received July 26, 2023

    Report

    Report Number
    9681834-2023-00142
    Event Type
    Malfunction
    Date Received
    July 26, 2023
    Date of Event
    June 27, 2023
    Report Date
    July 26, 2023
    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

    A4: WEIGHT: 6.04KGS. D4: UDI: N/A AS THIS PRODUCT IS NOT EXPORTED TO THE US MARKET. E3: OCCUPATION: CLINICAL ENGINEER. G4: PMA/510(K) - K130280. 1. INSPECTION OF THE ACTUAL SAMPLE: 1.1. VISUAL INSPECTION OF THE ACTUAL SAMPLE UPON RECEIPT FOUND NO ANOMALY SUCH AS A BREAKAGE. 1.2. THE ACTUAL SAMPLE WAS FILLED WITH GLUTARALDEHYDE-CONTAINING SALINE SOLUTION AND FIXED, THE HOUSING AND FILTER WERE REMOVED, AND VISUAL INSPECTION OF THE GAS TRANSFER PART WAS PERFORMED. NO ANOMALY WAS FOUND IN THE CONDITION OF FIBER WINDING. 1.3. THE FIBER LAYER WAS REMOVED GRADUALLY, AND VISUAL INSPECTION OF THE GAS TRANSFER PART WAS PERFORMED. FORMATION OF BLOOD CLOTS WAS OBSERVED THINLY THROUGHOUT THE GAS EXCHANGE PART. NO ANOMALY WAS FOUND IN THE CONDITION OF FIBER WINDING. 1.4. THE HEAT EXCHANGER WAS REMOVED FROM THE OUTER CYLINDER AND SUBJECTED TO VISUAL AND MAGNIFYING INSPECTION. FORMATION OF WHITE CLOTS WAS OBSERVED. NO DEFORMATION OR OTHER ANOMALY THAT COULD LEAD TO AN OBSTRUCTION WAS FOUND IN THE HEAT EXCHANGER. 2. REVIEW OF PUMP RECORD: PLT IN THE BLOOD TEST, THE VALUE RECORDED BEFORE THE START OF ECC WAS 35. 2 X 104/[?]L, WHILE THAT RECORDED UPON THE START OF ECC WAS FOUND TO HAVE DECREASED TO 10.9X104/L. THE RELATION BETWEEN THE PRESSURE DROP AND THE ARTERIAL BLOOD TEMPERATURE WAS CHECKED. AT THE TIMING WHEN THE ARTERIAL BLOOD TEMPERATURE WAS LOW, THE PRESSURE DROP INCREASED TO 130 MMHG. AFTER THE BODY TEMPERATURE WAS MAINTAINED NOT SO COOL, THE PRESSURE DROP INCREASED UP TO 220 MMHG. THE PRESSURE DROP HAD DECREASED TO 100MMHG WHEN RECORDED AT THE TIME OF REWARMING BEFORE THE END OF ECC. 3. HISTORY INVESTIGATION: REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE FOUND NO ANOMALY. REVIEW OF THE PAST COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT ON THE INVOLVED PRODUCT CODE/LOT NUMBER. MANUFACTURING DATE: FEBRUARY 21, 2023 4. CAUSE OF OCCURRENCE/CONCLUSION: THE INVESTIGATION RESULTS SHOWED THAT WHITE CLOTS WERE FORMED IN THE HEAT EXCHANGER OF THE ACTUAL SAMPLE. THE CAUSE OF OCCURRENCE WAS THOUGHT TO BE THE FORMATION OF BLOOD CLOTS IN THE HEAT EXCHANGER DUE TO SOME FACTOR, WHICH MAY HAVE CAUSED A CLOGGING IN THE OXYGENATOR, RESULTING IN THE INCREASING PRESSURE DROP. HOWEVER, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF FORMATION OF BLOOD CLOTS FROM THE CONDITION OF THE ACTUAL SAMPLE. RELEVANT IFU REFERENCE: "DO NOT REDUCE HEPARIN DURING CIRCULATION. OTHERWISE, BLOOD CLOTTING MIGHT OCCUR. ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED TO PREVENT IT FROM CLOTTING IN THE SYSTEM." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE PRESSURE DROP RAISED TO A LEVEL OF 130 MMHG IN 17 MINUTES AFTER CPB STARTED. IN RESPONSE TO A CALL FROM THE SURGICAL FIELD TO MAINTAIN THE BODY TEMPERATURE, REWARMING STARTED. IN 41 MINUTES WHEN TWO VENOUS LINES WERE USED, PRESSURE DROP REACHED TO 220 MMHG AS MAXIMUM. HOWEVER, THE PROCEDURE WAS MANAGED TO MAINTAIN WITHOUT EXCHANGING THE OXYGENATOR, AND AFTERWARD, IT DECREASED TO ABOUT 100MMHG. CPB COMPLETED WITH NO EXCHANGE OF OXYGENATOR. DESPITE INCREASING PRESSURE, IT SEEMED THAT EXCHANGE OF OXYGENATOR WAS AVOIDED BY MAINTAINING BODY TEMPERATURE WITHOUT COOLING THE PATIENT TOO MUCH. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1839511 CAPIOX FX05 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 230221

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Female CDI| S5