BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVANOS ON-Q PUMP

    MDR report key: 18536860 · Received January 17, 2024

    Report

    Report Number
    MW5150493
    Event Type
    Other
    Date Received
    January 17, 2024
    Date of Event
    December 14, 2023
    Report Date
    January 12, 2024
    Manufacturer
    AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
    Product Code
    MEB
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AVANOS ONQ PUMP (SELECT-A-FLOW, ON-DEMAND, MODEL CB006) HAD FAULTY DEMAND DOSE BUTTON. THE PATIENT WAS DISCHARGED AFTER SURGERY ON (B)(6) 2023 WITH AN ONQ PUMP. THAT NIGHT SHE PRESSED THE DEMAND DOSE BUTTON AND IT STAYED DOWN, DESPITE EFFORTS TO PRY THE BUTTON BACK UP. SHE REPORTED THE MEDICATION RAN CONTINUOUSLY FOR 2-3 MINUTES AND HER ARM FELT PROGRESSIVELY NUMB AND WEAK, AND HER BODY FELT WARM AND HER HEART RATE WAS FAST. HER HUSBAND USED SCISSORS TO CUT THE PNC (PERIPHERAL NERVE CATHETER) LINE. THEY PRESENTED TO THE EMERGENCY ROOM TO HAVE PNC REMOVED AND REPLACED. PER AVANOS REPRESENTATIVE, THE BUTTON SHOULD POP UP INSTANTANEOUSLY AFTER BEING PRESSED. THIS WAS BROUGHT TO THE ATTENTION OF OUR AVANOS REPRESENTATIVE AND THE PUMP WAS SENT TO THEM FOR INVESTIGATION. THIS IS THE 4TH PATIENT CASES OF PRODUCT MALFUNCTION IN THE SPAN OF 1 MONTH AT OUR HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065337 AVANOS ON-Q PUMP PUMP, INFUSION, ELASTOMERIC MEB AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) CB006

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Other