BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 13657357 · Received March 2, 2022

    Report

    Report Number
    9681834-2022-00018
    Event Type
    Injury
    Date Received
    March 2, 2022
    Date of Event
    January 19, 2022
    Report Date
    March 2, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701121
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K)- K130520. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. REVIEW OF THE MANUFACTURING RECORD AND THE PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT/LOT# COMBINATION CONFIRMED THERE WAS NO ANOMALY IN THEM. REGARDING THE INVOLVED PRODUCT CODE/LOT# COMBINATION, NO SIMILAR REPORT FROM OTHER FACILITIES WAS CONFIRMED IN THE COMPLAINT RECORDS; HOWEVER, THERE IS ONE SIMILAR REPORT FROM THE SAME FACILITY, WHICH IS UNDER THE INVESTIGATION AS THE ACTUAL SAMPLE FOR ANALYSIS HAS NOT YET BEEN RECEIVED. IFU STATES: "DO NOT USE AN OXYGENATOR THAT LEAKS." ACCORDING TO THE RESULTS OF THE INVESTIGATION, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE PRODUCT-RELEASE JUDGEMENT RECORD. THE ACTUAL SAMPLE WAS NOT AVAILABLE FOR ANALYSIS, IN ADDITION, THE OCCURRENCE SITUATION IN DETAILS SUCH AS THE EXACT LEAK POINT AND LEAKAGE STATUS WAS UNKNOWN; THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE CAPIOX OXYGENATOR HAD A LEAKING ISSUE, IN THE OXYGENATION MEMBRANE AREA. THEY CHANGED THE OXYGENATOR. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312137 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 200818 04987350701121

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other