BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIT ELECTRONIC PAIN CONTROL PUMP

    MDR report key: 16617742 · Received March 27, 2023

    Report

    Report Number
    16617742
    Event Type
    Malfunction
    Date Received
    March 27, 2023
    Date of Event
    February 9, 2023
    Report Date
    March 24, 2023
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AMBIT PAIN PUMPS MALFUNCTIONED WHEN UTILIZED ON PATIENTS. AVANOS MEDICAL PAIN PUMP PN#220527. WHEN AMBIT PAIN CONTROL SPIKE CASSETTE IS UTILIZED WITH PUMP DEVICE, CASSETTES ARE NOT FITTING PROPERLY AND CAUSING DIFFICULTY WHEN USING THE PRIMING DIAL. CASSETTE PN#220575. MANUFACTURER RESPONSE FOR PUMP, INFUSION, AMBIT* (PER SITE REPORTER) FACILITY IS CURRENTLY WORKING WITH REPRESENTATIVE FROM VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835585 AMBIT ELECTRONIC PAIN CONTROL PUMP PUMP, INFUSION FRN AVANOS MEDICAL, INC. 220527

    Patients

    Seq Age Sex Outcome Treatment
    1 29200 DA Female