BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX®FX

    MDR report key: 21148006 · Received January 14, 2025

    Report

    Report Number
    9681834-2024-00255
    Event Type
    Malfunction
    Date Received
    January 14, 2025
    Date of Event
    December 17, 2024
    Report Date
    January 14, 2025
    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

    A1: PATIENT INFORMATION: NO PATIENT INVOLVEMENT. 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 SAMPLE WAS DISCARDED BY THE INVOLVED FACILITY. NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL PRODUCT. NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER WAS FOUND. AS A CAUSE OF THIS CASE, IT WAS INFERRED THAT SINCE THE BUNDLED TUBE WAS PARTIALLY CROSSED, WHEN THE TUBE WAS STRAIGHTENED UP DURING SETTING, IT FORMED A KNOT. HOWEVER, SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND ITS CONDITION WAS UNKNOWN, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. 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 A KNOT IN THE SAMPLING LINE WAS FOUND DURING SET-UP. THEREFORE, THE RE-TRANSFUSION SIDE OF THE SAMPLING LINE WAS REMOVED, AND THE KNOT WAS UNTIED TO USE. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, THERE WAS NO PATIENT INVOLVED OR HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2012290 CAPIOX®FX OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX-XRX14501 240514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown