BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX®FX

    MDR report key: 24578911 · Received March 12, 2026

    Report

    Report Number
    9681834-2026-00049
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    February 17, 2026
    Report Date
    March 12, 2026
    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

    D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: CLINICAL ENGINEER. G4: 510(K) NO.: K130520. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL DEVICE FOUND NO ANOMALY. NO OTHER SIMILAR ISSUE HAS BEEN REPORTED. BASED ON THE INVESTIGATION RESULTS, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS. AS THE CAUSE OF THIS INCIDENT, IT WAS CONSIDERED NOT TO HAVE LEAKED DURING PRIMING OR AT THE START OF CIRCULATION SINCE A LEAK WAS OBSERVED AFTER APPROX. 7 HOURS OF USE IN OPERATION. HOWEVER, SINCE THE ACTUAL DEVICE WAS NOT RETURNED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF THE OCCURRENCE. RELEVANT INSTRUCTIONS FOR USE (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

    TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: LEAKAGE WAS OBSERVED AFTER THE CIRCUIT INCORPORATED THE OXYGENATOR (FX25W) WAS USED FOR APPROXIMATELY 7HOURS; THEREFORE, IT WAS REPLACED WITH ANOTHER OXYGENATOR (FX25E). OPE ITSELF HAD NO PROBLEM. A REPLACEMENT OF THE ARTIFICIAL LUNG WAS REQUIRED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641307 CAPIOX®FX OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX-XRX63701 250901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown