BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

    MDR report key: 12842937 · Received November 19, 2021

    Report

    Report Number
    9681834-2021-00204
    Event Type
    Injury
    Date Received
    November 19, 2021
    Date of Event
    October 25, 2021
    Report Date
    November 19, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350781772
    PMA / PMN Number
    K071572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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)- K130280. INITIAL REPORTER OCCUPATION- TECHNOLOGIST. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU STATES: MEASURE BLOOD GASES AND MAKE NECESSARY ADJUSTMENTS AS FOLLOWS. A.CONTROL PAO2 BY CHANGING CONCENTRATION OF OXYGEN IN VENTILATING GAS USING GAS BLENDER. TO DECREASE PAO2, DECREASE FIO2. TO INCREASE PAO2, INCREASE FIO2. B.CONTROL PACO2 BY CHANGING THE TOTAL GAS FLOW. TO DECREASE PACO2, INCREASE TOTAL GAS FLOW. TO INCREASE PACO2, DECREASE TOTAL GAS FLOW. 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 · 0

    THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX DEVICE WAS USED DURING THE PROCEDURE. THERE WAS AN ISSUE WITH THE TERUMO OXYGENATOR FX- 05 FAILURE. IN FX-05 PCO2 IS COMING HIGH AND PO2 IS COMING LOW ACCORDING TO THE SET VALUE ON PUMP. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744300 CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 210114 04987350781772

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other