BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIT ELECTRONIC INFUSION PUMP

    MDR report key: 25209008 · Received May 18, 2026

    Report

    Report Number
    2026095-2026-00045
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 18, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    FRN
    UDI-DI
    00193494000769
    PMA / PMN Number
    K162165
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND THE INVESTIGATION REMAINS IN PROGRESS AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 18 MAY 2026 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AN AMBIT ELECTRONIC INFUSION PUMP WAS USED FOR POSTOPERATIVE PAIN MANAGEMENT FOLLOWING TREATMENT FOR MULTIPLE RIB FRACTURES. THE PUMP WAS INITIATED ON (B)(6) 2026 USING ROPIVACAINE HCL 0.2% WITH PROGRAMMED SETTINGS OF 12 ML EVERY 3 HOURS WITH OPTIONAL PATIENT BOLUS DOSING OF 3 ML EVERY 3 HOURS. ON (B)(6) 2026, THE PHYSICIAN¿S ASSISTANT IDENTIFIED A POSSIBLE FAST FLOW/OVERINFUSION CONDITION. THE PATIENT WAS ADMITTED/TRANSFERRED TO THE SURGICAL INTENSIVE CARE UNIT (SICU) FOR MONITORING. THE CUSTOMER REPORTED THE DEVICE HAD BEEN USED WITH AN ASSOCIATED AVANOS CATHETER/CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606166 AMBIT ELECTRONIC INFUSION PUMP ELECTRONIC INFUSION PUMPS & SYSTEMS FRN AVANOS MEDICAL INC. 220527 30230297 00193494000769

    Patients

    Seq Age Sex Outcome Treatment
    1