BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENFLOW IV FLUID/BLOOD WARMER

    MDR report key: 12478071 · Received September 15, 2021

    Report

    Report Number
    3008959444-2021-00010
    Event Type
    Injury
    Date Received
    September 15, 2021
    Date of Event
    July 22, 2021
    Report Date
    August 16, 2021
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    LGZ
    UDI-DI
    10190752125780
    PMA / PMN Number
    K130867
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE AND HTI, CONDUCTED AN INVESTIGATION AND PERFORMED A TEST WITH THE ENFLOW TEST SETUP WHERE THE ORIGINAL ISSUE HAS BEEN OBSERVED. CONTROLLER DISPLAYS "NOT HEATING", HOWEVER AS SEEN IN THE THERMOMETER DISPLAY, WARMER IS CAPABLE TO WARM THE CARTRIDGE UP TO 39.2 °C.IT ONLY CANNOT SEND THE TEMPERATURE MEASUREMENT TO THE CONTROLLER. THE WARMERS RECEIVED IN 2021 HAVE PASSED FUNCTIONALITY TEST WITH THE OLDER CONTROLLER. WHEN FUNCTIONAL TESTER HAS BEEN REPLACED WITH A NEWER ONE, POOR CONNECTION ISSUE WAS OBSERVED AT HTI. THERE IS A PROBABILITY OF POOR CONNECTION AMONG THE WARMERS IN VYAIRE INVENTORY. POOR DATA CONNECTION IS CAUSED BY THE HUBBELL PLUG INNER DIAMETER BEING OUT OF NEMA STANDARD SPECIFICATION (4.19-4.32 MM), WHEN HUBBELL PLUG IS INSERTED IN THE HUBBELL RECEPTACLE. THIS ONLY IMPACTS THE DATA, NOT POWER. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE STUDY NURSE WAS PREPARING THE ENFLOW DEVICES (WARMER, CARTRIDGE, AND CONTROLLER) WITH THE TRAINED ANESTHETIST NURSE BEFORE THE SURGERY. WHEN THE ENFLOW WARMER WITH THE CARTRIDGE WAS CONNECTED TO THE CONTROLLER, THE TEXT "NOT HEATING" WAS SHOWING ON THE CONTROLLER'S SCREEN. DESPITE THE TEXT, IT WAS STATED THAT THE WARMER FELT WARM. THE STUDY NURSE REPLACED THE WARMER, AND THE TEXT DID NOT REAPPEAR AGAIN. IT HAPPENED DURING PATIENT USE, BUT NO HARM IS ASSOCIATED WITH THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375378 ENFLOW IV FLUID/BLOOD WARMER WARMER, THERMAL, INFUSION FLUID LGZ VYAIRE MEDICAL ENFLOW IV FLUID/BLOOD WARMER NOT APPLICABLE 10190752125780

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention