BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX®FX

    MDR report key: 21364511 · Received February 12, 2025

    Report

    Report Number
    9681834-2025-00013
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    January 10, 2025
    Report Date
    February 7, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350781758
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED ON 07FEB2025 HOWEVER THE REPORT NUMBER WAS INADVERTENTLY SUBMITTED AS 9681834-2024-00013 INSTEAD OF THE CORRECT NUMBER WHICH SHOULD HAVE BEEN. BECAUSE OF THAT ERROR, THE REPORT FAILED AS A DUPLICATE AND IS BEING RESUBMITTED WITH THE CORRECT REPORT NUMBER. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: PERFUSIONIST. G4: PMA/510(K): K130280. THE ACTUAL DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. 1. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL PRODUCT: NO ANOMALY WAS FOUND. 2. PAST COMPLAINT FILE: NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT# WAS FOUND. 3. MANUFACTURING DATE: SEPTEMBER 25, 2023. 4. CAUSE OF OCCURRENCE/CONCLUSION: BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS. ALTHOUGH THE ONE-WAY VALVE FOR THE INVOLVED PRODUCT WAS INSTALLED IN THE SAMPLING LINE AND PURGE LINE, SINCE THE ACTUAL SAMPLE 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 FX05 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 THEY HAD A LEAKY VALVE IN THE FX05. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856281 CAPIOX®FX OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX*FX05RE 230925 04987350781758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown