BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK CAPIOX

    MDR report key: 8654133 · Received May 30, 2019

    Report

    Report Number
    9681834-2019-00087
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    April 4, 2019
    Report Date
    May 30, 2019
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN PRODUCT CODE/ LOT NUMBER. UDI - UNKNOWN DUE TO UNKNOWN PRODUCT CODE/ LOT NUMBER. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURE DATE - UNKNOWN DUE TO UNKNOWN PRODUCT CODE/ LOT NUMBER. HEALTH PROFESSIONAL: UNKNOWN. OCCUPATION: UNKNOWN. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE PRODUCTION PRODUCT CODE/ LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. WITH NO RETURN OF THE ACTUAL DEVICE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED CLOTTING PER CEC IN THE CARDIOTOMY RESERVOIR OF A CEC CIRCUIT IN A TERUMO BRAND SET. THE PROCEDURE OUTCOME WAS REPORTED TO BE UNKNOWN. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448087 UNK CAPIOX OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1