BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 12364259 · Received August 25, 2021

    Report

    Report Number
    9681834-2021-00150
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    August 4, 2021
    Report Date
    August 25, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701121
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510K: PMA/510(K)- K130520. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE IMAGE PROVIDED BY THE USER SHOWED THAT THE LOCK ADAPTER HAD COME OFF THE MALE CONNECTOR OF THE SAMPLING SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IT WAS LIKELY IF SOME SUBSTANCE THAT COULD WORK LIKE A LUBRICANT WAS ADHERED TO THE MALE CONNECTOR, THE LOCK ADAPTER MIGHT BECOME DISLODGED WHEN TIGHTENED UP. HOWEVER, WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS USED PRE-TREATMENT. DURING SET UP, THE USER FOUND THAT THE SAMPLING MANIFOLD WAS BROKEN. THEY DECIDED TO NOT USE THIS ITEM AND CHANGE. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264060 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 210118 04987350701121

    Patients

    Seq Age Sex Outcome Treatment
    1