BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 15482085 · Received September 25, 2022

    Report

    Report Number
    9681834-2022-00194
    Event Type
    Malfunction
    Date Received
    September 25, 2022
    Date of Event
    August 28, 2022
    Report Date
    September 25, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701046
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. INITIAL REPORTER OCCUPATION: PERFUSIONIST. PMA/510(K): K071494, K130520. THE ACTUAL DEVICE WAS DISCARDED BY THE INVOLVED FACILITY; THEREFORE, THE ACTUAL DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE PROVIDED VIDEO OF THE EVENT SHOWED THAT THE MALE AND FEMALE CONNECTORS OF THE SAMPLING LINE LEADING TO THE OXYGENATOR COULD NOT BE UNCOUPLED. REVIEW OF THE MANUFACTURING HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE CONFIRMED THAT THERE WERE NOT ANY ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. THE PART IN QUESTION OF THIS PRODUCT IS MANUALLY MATED BY THE OPERATORS IN THE PRODUCTION PROCESS. THEREFORE, IT WAS CONSIDERED POSSIBLE THAT THE MATING WAS MADE TIGHTER THAN USUAL DUE TO THE VARIATION OF OPERATORS, MAKING IT DIFFICULT TO UNCOUPLE IN THIS CASE. HOWEVER, SINCE WE COULD NOT CHECK THE ACTUAL SAMPLE, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE CONNECTORON THE CAPIOX FX25 RECIRCULATION LINE COULD NOT BE OPENED. THE PROCEDURE OUTCOME WAS NOT REPORTED. IT IS UNKNOWN IF ANY OTHER DEVICES OR EQUIPMENT WERE USED WITH THE REPORTED PRODUCT. THE EVENT OCCURED PRE-TREATMENT, THEREFORE THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337687 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 211126 04987350701046

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown