BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 15623742 · Received October 18, 2022

    Report

    Report Number
    9681834-2022-00218
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    October 4, 2022
    Report Date
    October 18, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701121
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: REQUESTED, UNKNOWN. DATE OF BIRTH: REQUESTED, UNKNOWN. ETHNICITY: REQUESTED, UNKNOWN. RACE: REQUESTED, UNKNOWN. OCCUPATION: PERFUSIONIST. PMA/510(K) - K130520. THE ACTUAL DEVICE WAS NOT AVAILABLE; THEREFORE, THE ACTUAL DEVICE WILL NOT BE RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE CONFIRMED THAT THERE WAS NOT ANY ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION. ACCORDING TO THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS OF THE ACTUAL SAMPLE. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND THE ANALYSIS OF IT COULD NOT BE PERFORMED, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. RELEVANT IFU REFERENCE: "DO NOT USE AN OXYGENATOR AND RESERVOIR THAT LEAKS. REPLACE IT WITH ANOTHER CAPIOX FX15 OXYGENATOR AND RESERVOIR." (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE CAPIOX FX15 OXYGENATOR INVOLVED LEAKED AT THE CONNECTOR SITE DURING PRIMING. THE EVENT OCCURRED PRE-TREATMENT. THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2482978 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 210420 04987350701121

    Patients

    Seq Age Sex Outcome Treatment
    1 Male