BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX05 OXYGENATOR

    MDR report key: 16917713 · Received May 12, 2023

    Report

    Report Number
    9681834-2023-00080
    Event Type
    Malfunction
    Date Received
    May 12, 2023
    Date of Event
    April 14, 2023
    Report Date
    May 12, 2023
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    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

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP 1 TO CORRECT SECTION D1 BRAND NAME AS THE INITIAL REPORT INADVERTENTLY HAD THE WRONG INFORMATION.

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: NO PATIENT INVOLVEMENT. A2: AGE & DATE OF BIRTH: NO PATIENT INVOLVEMENT. A3: PATIENT SEX: NO PATIENT INVOLVEMENT. A4: WEIGHT: NO PATIENT INVOLVEMENT. A5: ETHNICITY: NO PATIENT INVOLVEMENT. A6: RACE: NO PATIENT INVOLVEMENT. D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: NO PATIENT INVOLVEMENT. D6B: EXPLANTED DATE: NO PATIENT INVOLVEMENT. E3: OCCUPATION: (B)(6). G4: PMA/510(K) - K071494, K130520. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL SAMPLE REVEALED: (I) NO ANOMALY SUCH AS DAMAGE THAT COULD LEAD TO AIR MIXING WAS FOUND; (II) NO ANOMALY IN THE APPEARANCE WAS FOUND AT THE FUSED SECTION OF FILTER LOCATED ON THE TOP SURFACE OF OXYGENATOR. CIRCULATION TEST OF THE ACTUAL SAMPLE WAS CONDUCTED. SALINE SOLUTION WAS CIRCULATED WITH A FLOW RATE OF 1 L/MIN, AND REMOVAL OPERATION FOR BUBBLE WAS PERFORMED. AS A RESULT, NO AIR WAS MIXED. WHILE SALINE SOLUTION WAS BEING CIRCULATED WITH FLOW RATES OF 0.25 L/MIN, 0.5 L/MIN, AND 1.0 L/MIN RESPECTIVELY, AIR WAS INTENTIONALLY FLOWED FROM THE INLET SIDE OF OXYGENATOR USING A SYRINGE. AS A RESULT, NO AIR WAS FLOWED OUT. THE ASHITAKA FACTORY, HAVE EXPERIENCED AIR MIXING DUE TO THE APPLICATION OF NEGATIVE PRESSURE INSIDE THE OXYGENATOR. THE FOLLOWING SIMULATION TEST WAS PERFORMED USING THE ACTUAL SAMPLE. (I) WHEN THE LOWERMOST PART OF OXYGENATOR IS POSITIONED HIGHER THAN THE LIQUID LEVEL OF RESERVOIR, NEGATIVE PRESSURE IS APPLIED INSIDE THE OXYGENATOR AND AIR IS MIXED IN THROUGH THE FIBERS. IN THIS STATE, AIR PASSES THROUGH THE FILTER WHEN AN AIR RELEASE OPERATION SUCH AS TAPPING THE OXYGENATOR IS PERFORMED. (II) WHEN SUCTION IS PERFORMED BY A PUMP FROM THE OUTLET SIDE OF OXYGENATOR (WHEN THE AMOUNT OF SUCTION AT THE OUTLET SIDE OF OXYGENATOR IS GREATER THAN THE MAIN FLOW RATE), NEGATIVE PRESSURE IS APPLIED INSIDE THE OXYGENATOR, AND AIR IS MIXED THROUGH THE FIBER. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE. NO ANOMALY WAS FOUND. NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER WAS FOUND. BASED ON THE INVESTIGATION RESULT, NO ANOMALY THAT COULD LEAD TO AIR MIXING WAS FOUND IN THE ACTUAL SAMPLE. AS A POSSIBLE CAUSE OF OCCURRENCE, IT WAS INFERRED THAT DUE TO SOME FACTOR, NEGATIVE PRESSURE WAS APPLIED TO THE OXYGENATOR, AND AIR WAS MIXED THROUGH THE FIBER. HOWEVER, SINCE NO ANOMALY WAS FOUND IN THE ACTUAL SAMPLE, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF THIS CASE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: (I) WHEN CAPIOX FX05 OXYGENATOR MODULE IS USED SEPARATELY FROM THE HARDSHELL RESERVOIR, SET THE MODULE SO THAT THE UPPER END OF THE FIBERS IS LOWER THAN THE BLOOD LEVEL IN THE VENOUS RESERVOIR. THIS PREVENTS GASEOUS EMBOLI FROM ENTERING THE BLOOD PHASE FROM THE GAS PHASE. (WARNINGS). (I) TO PREVENT GASEOUS EMBOLI FROM ENTERING THE BLOOD PHASE, MAKE SURE THAT THE ARTERIAL PUMP FLOW RATE ALWAYS EXCEEDS THE FLOW RATE OF THE CARDIOPLEGIA LINE. THE BLOOD FLOW RATE OF THE CARDIOPLEGIA LINE SHOULD NOT EXCEED 0.5L/MIN. (WARNINGS) (II) DURING RECIRCULATION, DO NOT USE PULSATILE FLOW AND DO NOT STOP THE BLOOD PUMP SUDDENLY AS THESE ACTIONS MAY CAUSE GASEOUS EMBOLI TO ENTER THE BLOOD PHASE FROM THE GAS PHASE DUE TO INERTIA FORCE. (WARNINGS). 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 INVOLVED CAPOIX DEVICE AIR WAS NOT VENTED DURING PRIMING. AN EVENT OCCURRED WHERE VISIBLE AIR CONTINUED TO COME OUT FROM THE OUTSIDE OF FX05 FILTER. DURING PRIMING, THE OXYGENATOR IS REMOVED FROM THE RESERVOIR AND TAPPED WITH FORCEPS. AS THE TIME FOR THE PATIENT TO ENTER THE ROOM WAS APPROACHING, IT WAS REPLACED WITH ANOTHER FX05 PRODUCT TO USE. THE EVENT OCCURRED PRE-TREATMENT, WITH NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358160 CAPIOX FX05 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 220627

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown