BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 20189693 · Received September 11, 2024

    Report

    Report Number
    9681834-2024-00159
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 17, 2024
    Report Date
    September 11, 2024
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350781772
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED . A2: DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3B: GENDER: REQUESTED, NOT PROVIDED. A4: WEIGHT: 5.5KGS. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED . D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: CONTACT: REQUESTED, UNKNOWN. E1: TELEPHONE NUMBER: REQUESTED, UNKNOWN. G4: PMA/510(K): K130280. THE PROVIDED IMAGES OF THE ACTUAL SAMPLE REVEALED THE FOLLOWING: THE OXYGENATOR WAS NOT FILLED WITH BLOOD, AND AIR WAS MIXED IN. THE OXYGENATOR WAS TINTED RED UP TO THE UPPER PART OF THE FILTER, INDICATING THAT THE ACTUAL SAMPLE WAS PREVIOUSLY FILLED COMPLETELY WITH BLOOD. THERE WAS NO BLOOD FLOWING THROUGH THE PURGE LINE. VISUAL INSPECTION OF THE ACTUAL SAMPLE DID NOT IDENTIFY ANY ANOMALIES SUCH AS BREAKAGE THAT COULD RESULT IN AIR INGRESS. THE ACTUAL SAMPLE UNDERWENT CLEANING AND WAS SUBJECTED TO THE AIR BUBBLE REMOVAL PERFORMANCE TEST. IT WAS INSTALLED INTO A CIRCUIT CONSISTING OF TUBING AND FILLED WITH SALINE SOLUTION. THE SALINE SOLUTION WAS THEN REPLACED WITH BOVINE BLOOD. DURING CIRCULATION WITH A FLOW RATE OF 1.5L/MIN, THE PRIMING PROCESS WAS SUCCESSFULLY COMPLETED WITHOUT ANY AIR MIXING IN. SUBSEQUENTLY, WHILE CIRCULATING BOVINE BLOOD UNDER THE FOLLOWING CONDITIONS, 10 ML OF AIR WAS INTRODUCED INTO THE ACTUAL SAMPLE FROM THE BLOOD INLET PORT SIDE. IT WAS OBSERVED THAT NO AIR FLOWED OUT FROM THE OXYGENATOR THROUGH THE FILTER. (*NOTE: AN ARTERIAL FILTER IS CONNECTED TO THE BLOOD OUTLET PORT SIDE TO CHECK IF AIR FLOWING OUT TO THE OXYGENATOR AND THE ARTERIAL FILTER.) [BLOOD CONDITIONS] HB: 12 G/DL, TEMPERATURE: 37°C [CIRCULATION CONDITIONS] BLOOD FLOW RATE: 0.5 L/MIN, 1.0 L/MIN, AND 1.5 L/MIN. BACK PRESSURE: 200 MMHG. SIMULATION TEST BASED ON THE PROVIDED IMAGE OF THE ACTUAL SAMPLE DURING USE, WHERE NO BLOOD FLOW WAS OBSERVED THROUGH THE PURGE LINE, IT WAS THOUGHT THAT THE PURGE LINE WAS CLOSED. THE IFU OF THIS PRODUCT STATES IN THE PRIMING PROCEDURE SECTION, "REMOVE THE AIR WHILE OPENING THE PURGE LINE." TO ASSESS THE EASE OF AIR REMOVAL DEPENDING ON WHETHER THE PURGE LINE IS OPEN OR CLOSED, THE FOLLOWING SIMULATION TEST WAS CONDUCTED. AIR WAS INTENTIONALLY INJECTED INTO THE OXYGENATOR AFTER PRIMING WAS COMPLETED, AND THEN BOVINE BLOOD WAS CIRCULATED AT A FLOW RATE OF 1.5 L/MIN. IT WAS CONFIRMED THAT AIR ESCAPED FROM THE PURGE LINE WHEN THE PURGE LINE WAS OPEN. CONVERSELY, WHEN THE PURGE LINE WAS CLOSED, NO AIR ESCAPED, THUS REPLICATING THE SITUATION OBSERVED DURING THE EVENT. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE NO ANOMALY WAS FOUND IN THEM. PAST COMPLAINT FILE OF THE INVOLVED PRODUCT CODE/LOT NO SIMILAR COMPLAINT WAS RECEIVED. MANUFACTURING DATE: DECEMBER 4, 2023 EXPIRATION DATE: NOVEMBER 30, 2026 CAUSE OF OCCURRENCE/CONCLUSION BASED ON THE INVESTIGATION RESULTS, NO ANOMALIES THAT WOULD RESULT IN AIR MIXING INTO THE ACTUAL SAMPLE WERE OBSERVED. BASED ON THE PROVIDED IMAGES, IT WAS INFERRED THAT DISCHARGING AIR WAS DIFFICULT BECAUSE THE PURGE LINE WAS CLOSED. AS NO ISSUES WERE IDENTIFIED IN THE ACTUAL SAMPLE, THE EXACT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. RELEVANT IFU REFERENCE: "AFTER PRIMING, IF AIR BUBBLES CONTINUE TO APPEAR, IDENTIFY THE CAUSE AND MAKE NECESSARY CORRECTIONS. REMOVE THE AIR WHILE OPENING THE PURGE LINE." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED LEAKAGE, THE PRIMING SOLUTION COULD NOT BE PUMPED INTO THE OXYGENATOR AND FILL THE CHAMBER, WHICH WERE FILLED WITH AMOUNTS OF BUBBLES. THEN A NEW DEVICE WAS REPLACED TO COMPLETE THE OPERATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510962 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX*FX05RW 231204 04987350781772

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Female