BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX®FX

    MDR report key: 20488314 · Received October 18, 2024

    Report

    Report Number
    9681834-2024-00179
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    September 19, 2024
    Report Date
    October 18, 2024
    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: PMA/510(K): 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 SAMPLE NO ANOMALY WAS FOUND. PAST COMPLAINT FILE NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT# WAS FOUND. MANUFACTURING DATE: MAY 23, 2024. CAUSE OF OCCURRENCE/CONCLUSION BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD. SINCE THE ACTUAL SAMPLE COULD NOT BE INVESTIGATED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF TEMPERATURE MEASUREMENT FAILURE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "DO NOT USE IF THE PACKAGE OR DEVICE IS DAMAGED (E.G. CRACKED) OR ANY OF THE PORT CAPS ARE OFF." TERUMO MEDICAL PRODUCTS (TMP) (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 WHILE PRIMING THE CARDIOPULMONARY BYPASS CIRCUIT, THE TEMPERATURE DISPLAY FLUCTUATED WILDLY BETWEEN 20°C AND 36°C. THE THERMISTOR CORD WAS REPLACED AND EXTRACORPOREAL CIRCULATION WAS PERFORMED. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2220212 CAPIOX®FX OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX-XRX35702 240523

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown