BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPIOX®FX

    MDR report key: 22343103 · Received June 27, 2025

    Report

    Report Number
    9681834-2025-00117
    Event Type
    Death
    Date Received
    June 27, 2025
    Date of Event
    June 1, 2025
    Report Date
    June 26, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701046
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED E3: OCCUPATION: PERFUSIONIST G4: 510K: K1300520. THE ACTUAL DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL DEVICE - NO ANOMALY WAS FOUND. PAST COMPLAINT FILE - NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER WAS FOUND. CAUSE OF OCCURRENCE/CONCLUSION BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS. SINCE THE ACTUAL DEVICE COULD NOT BE INVESTIGATED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. RELEVANT IFU REFERENCE: "DO NOT USE AN OXYGENATOR AND RESERVOIR THAT LEAKS. REPLACE IT WITH ANOTHER CAPIOX FX25 OXYGENATOR AND RESERVOIR." TERUMO MEDICAL CORPORATION (TMC) (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 A SMALL BLOOD LEAK ARE DETECTED AT THE ARTERIAL CONNECTION PORT OUTLET DURING THE SETUP OF THE EXTRACORPOREAL CIRCUIT FOR THE PATIENT'S SURGERY. THE ISSUE WAS IDENTIFIED WHEN THE CIRCUIT WAS PRIMED. SINCE THE PATIENT WAS ALREADY CONNECTED TO THE CARDIOPULMONARY BYPASS (CPB) AND THERE WAS INSUFFICIENT TIME TO REPLACE THE CIRCUIT, THE LEAK WAS RESOLVED BY APPLYING A TEGADERM TO PREVENT A HIGH-RISK SITUATION. THE PATIENT EXPERIENCED HYPOTENSION AND AIRWAY BLEEDING, WHICH WAS THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002673 CAPIOX®FX OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX*FX25RW 241114 04987350701046

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Death