BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANOS AMBIT CASSETTE WITH SPIKE CONNECTOR

    MDR report key: 20038293 · Received August 21, 2024

    Report

    Report Number
    MW5158719
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    August 15, 2024
    Report Date
    August 19, 2024
    Manufacturer
    AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
    Product Code
    OFQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE AVANOS AMBIT CASSETTE WITH SPIKE CONNECTOR TUBING (REF: 220140, LOT# 30225606, EXP: 09-19-2025) EXHIBITED LEAKING FROM THE CASSETTE SITE WHEN PRIMED WITH DRUG/MEDICATION. WHEN WE ATTEMPTED TO USE ANOTHER TUBING FROM THIS SAME LOT, WE ALSO SAW LEAKAGE OCCUR. THIS HAPPENED AT LEAST 3 TIMES, AND THE PATIENT ABOVE RETURNED DUE TO PUMP LEAKAGE FROM CASSETTE THAT WAS NOT IDENTIFIED WHEN PRIMED. FROM OUR ESTIMATE, MOST OF THE TUBING FROM THIS LOT IS AFFECTED BY LEAKING. WE CONTACTED THE MANUFACTURER TO INFORM THEM OF THE ISSUE AND INCLUDED THE ATTACHED PICTURES AND ARE AWAITING A RESPONSE. IN THE MEANTIME, WE HAVE DECIDED TO USE ALTERNATE TUBING FROM A DIFFERENT LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364720 AVANOS AMBIT CASSETTE WITH SPIKE CONNECTOR ANESTHESIA KIT OFQ AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) 220140 30225606

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other INFUSION PUMP