BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 10055769 · Received May 14, 2020

    Report

    Report Number
    9681834-2020-00078
    Event Type
    Injury
    Date Received
    May 14, 2020
    Date of Event
    April 3, 2020
    Report Date
    May 14, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701046
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT CODE/ LOT # COMBINATION WAS CONDUCTED WITH NO FINDINGS. REGARDING THE FIBER LOT HAVING BEEN USED FOR THIS PRODUCT CODE/ LOT #, THE GAS-TRANSFER PERFORMANCE TEST CONDUCTED IN THE SHIPPING INSPECTIONS SHOWED THAT THIS FIBER LOT SATISFIED THE MANUFACTURER SPECIFICATION. THE PUMP RECORD INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR REVIEW. IFU STATES: UPON PATIENT REWARMING, ADJUST O2 CONCENTRATION, GAS FLOW RATE AND BLOOD FLOW RATE BY INCREASING THEM AS NEEDED BASED ON AN INCREASE IN PATIENT'S METABOLISM. FAILURE TO ADJUST THE GAS SUPPLY AND THE BLOOD FLOW RATE APPROPRIATELY MAY CAUSE INSUFFICIENT O2 SUPPLY NEEDED OR THE AMOUNT OF THE PATIENT'S GASEOUS METABOLISM. MEASURE BLOOD GASES AND MAKE NECESSARY ADJUSTMENTS AS FOLLOWS. CONTROL PAO2 BY CHANGING CONCENTRATION OF OXYGEN IN VENTILATING GAS USING GAS BLENDER. TO DECREASE PAO2, DECREASE FIO2. TO INCREASE PAO2, INCREASE FIO2. BASED ON THE COMPLAINT DESCRIPTION THAT THE USER EXPERIENCED THE OXYGENATION PROBLEM WHILE CONTINUOUSLY REWARMING TO 37°, IT IS LIKELY THAT THE VOLUME OF SUPPLIED O2 BECAME INSUFFICIENT FOR THE O2 CONSUMPTION VOLUME THAT INCREASED DUE TO THE PATIENT'S METABOLISM ACTIVATED BY THE REWARMING, RESULTING IN A DECREASE IN SVO2. HOWEVER, SINCE THE PATIENT DEMOGRAPHIC (BSA, HEIGHT) AND THE CIRCULATION CONDITION (FLOW RATE, FIO2) WERE UNKNOWN, AND WITH NO RETURN OF THE ACTUAL DEVICE, 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 INVOLVED CAPIOX DEVICE WAS USED DURING THE PROCEDURE. WHILE ON CARDIOPULMONARY BYPASS, AFTER REMOVAL OF THE CROSS CLAMP AND CONTINUOUSLY REWARMING TO 37 DEGREES, THEY EXPERIENCED A PROBLEM WITH OXYGENATION. THE PERFUSIONIST CHECKED THE POSSIBLE CAUSE; THE BLOOD FLOW WAS ON 2.4 CARDIAC INDEX AND THEY CONFIRMED THAT THE GAS SUPPLY WAS SECURELY CONNECTED TO THE OXYGENATOR. THEY CHANGED THE SOURCE OF OXYGEN WITH A NEW OXYGEN TANK; HOWEVER, THERE WAS STILL A PERSISTENT HYPOXEMIA DESPITE OF ALTERNATIVE O2 SUPPLY. THE ARTERIAL BLOOD OF THE PATIENT BECAME BLACK IN COLOR MEANING THERE WAS NOT ENOUGH OXYGEN IN THE BLOOD. THE PATIENT AND PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523500 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 191111K 04987350701046

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| S