BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLENDER

    MDR report key: 8599906 · Received May 10, 2019

    Report

    Report Number
    2021710-2019-10245
    Event Type
    Injury
    Date Received
    May 10, 2019
    Date of Event
    February 1, 2019
    Report Date
    April 15, 2019
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    BZR
    UDI-DI
    10846446002126
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE MEDICAL RECEIVED UF REPORT: (B)(4). VYAIRE MEDICAL, INC. REACHED OUT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION. THE SERIAL NUMBER WAS PROVIDED AND CONFIRMED. BASED ON THE INFORMATION PROVIDED IN THE UF REPORT: (B)(4), THE BIOMED REPORTED THE DEVICE WAS REPAIRED AND RETURNED BACK TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE UNDERGOING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) POST OXYGENATOR THERAPY, THE PATIENT'S PARTIAL-ARTERIAL OXYGEN (PA02) LEVEL IS READING SEVENTY (70) MMHG. THE CUSTOMER PERFORMED TROUBLESHOOTING. THE OXYGEN TUBING AND FILTER WAS CHANGED. THE CUSTOMER REPORTED NO IMPROVEMENTS TO THE PATIENT WERE REPORTED WITH THE POST OXYGENATOR PA02 GREATER THAN 500 MMHG. THE CUSTOMER DETERMINED THE MOST LIKELY CAUSE OF THE ISSUE WAS DUE TO THE BLENDER DIAL KNOB. THE CUSTOMER REPORTED IT FOUND TO BE LOOSE. THE CUSTOMER REPORTED VERIFIED THE DEVICE WITH AN ANALYZER CHECK AND REPORTED READING ONLY TWENTY-ONE PERCENT (21%) OXYGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393291 BLENDER MIXER, BREATHING GASES, ANESTHESIA INHALATION BZR VYAIRE MEDICAL BLENDER 10846446002126

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA Required Intervention