BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX®FX

    MDR report key: 22037113 · Received May 16, 2025

    Report

    Report Number
    9681834-2025-00079
    Event Type
    Injury
    Date Received
    May 16, 2025
    Date of Event
    April 23, 2025
    Report Date
    May 16, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701169
    PMA / PMN Number
    K071494
    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 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: UNKNOWN E1: ESTABLISHMENT ADDRESS: UNION HOSPITAL, TONGJI MEDICAL COLLEGE, HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY E1: PHONE NUMBER: UNKNOWN E3: OCCUPATION: TECHNOLOGIST. G4: 510K: K130520. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL DEVICE. NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER WAS FOUND. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE DEVICE RETURN DATE IN SECTION D9, UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. CONFIRMATION OF THE PROVIDED VIDEO. IT WAS FOUND THAT A RED, TRANSPARENT LIQUID HAD BEEN FLOWED OUT OF THE GAS OUTLET SIDE. VISUAL INSPECTION OF THE ACTUAL DEVICE UPON RECEIPT: NO ANOMALY SUCH AS DAMAGE WAS FOUND. LEAK TEST OF THE ACTUAL DEVICE: THE ACTUAL DEVICE (AFTER RINSING) WAS INSTALLED INTO A CIRCUIT CONSISTING OF TUBES, AND THE COLORED SALINE SOLUTION WAS CIRCULATED. AS A RESULT, NO LEAKAGE WAS FOUND. THE INSIDE OF HOUSING ON THE GAS CHANNEL SIDE WAS CONFIRMED WHEN THE BLOOD OUTLET PORT SIDE WAS BLOCKED AND 2KGF/CM2 AIR PRESSURE WAS APPLIED TO THE BLOOD CHANNEL FROM THE BLOOD INLET PORT SIDE. AS A RESULT, NO LEAKAGE WAS FOUND. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL DEVICE FOUND NO ANOMALY. PAST COMPLAINT FILE. NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER WAS FOUND. BASED ON THE INVESTIGATION RESULT, IT WAS LIKELY THAT WHEN USING THE ACTUAL DEVICE, PLASMA LEAKAGE OCCURRED, AND IT WAS FOUND THAT LIQUID WAS LEAKING FROM THE GAS OUTLET SIDE. AS A POSSIBLE CAUSE OF PLASMA LEAKAGE, FROM OUR PAST EXPERIENCE, FOLLOWING FACTOR WAS INFERRED. HOWEVER, SINCE NO ANOMALY LEADING TO THE LEAKAGE WAS FOUND ON THE ACTUAL DEVICE, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. THE BLOOD PROPERTIES CHANGED DUE TO SOME FACTORS, A SUBSTANCE HAVING A SURFACE-ACTIVE ACTION WAS PRODUCED, AND THE RELATIONSHIP BETWEEN THE SURFACE TENSION OF BLOOD AND GAS MAINTAINED IN THE MICROPORES OF FIBER SURFACE WAS BROKEN. THIS CAUSED THE FIBER TO BECOME HYDROPHILIC, LEADING TO PLASMA LEAKAGE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THERE WAS BLOOD LEAKAGE FROM THE OXYGENATION. DURING THE PROCESS OF MITRAL VALVE MECHANICAL REPLACEMENT SURGERY, IT WAS DISCOVERED THAT THERE WAS BLOOD LEAKAGE FROM THE OXYGENATOR WHILE THE CBP HAD NOT EVEN. ONCE THE MACHINE WAS RUNNING, THE SPEED OF LEAKAGE INCREASED. IN AN EMERGENCY SITUATION, THE OXYGENATOR BIN WAS REPLACED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2103300 CAPIOX®FX OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX*FX15RW30 250107 04987350701169

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female