BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 18160995 · Received November 17, 2023

    Report

    Report Number
    9681834-2023-00221
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Date of Event
    October 16, 2023
    Report Date
    November 17, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K071572
    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. G4: PMA/510(K): K130280. E3: OCCUPATION: CLINICAL ENGINEER. THE ACTUAL SAMPLE WAS DISCARDED BY THE INVOLVED FACILITY. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL PRODUCT FOUND NO ANOMALY. NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER WAS FOUND. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD OF THE ACTUAL PRODUCT. SINCE THE ACTUAL SAMPLE COULD NOT BE INVESTIGATED, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. 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. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE CAPIOX FX25 DEVICE DISPLAYED THAT THE ARTERIAL TEMPERATURE AND VENOUS TEMPERATURES WERE UNSTABLE AND NOT WORKING PROPERLY. ALTHOUGH THE TEMPERATURE PROBE WAS REPLACED WITH A NEW ONE, THE SAME EVENT OCCURRED. VENOUS TEMPERATURE AND ARTERIAL TEMPERATURE WERE GENERALLY UNSTABLE; HOWEVER, DISAPPEARED HALFWAY. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1745285 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO MEDICAL CORPORATION N/A 230419

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown