BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIT ELECTRONIC PAIN CONTROL PUMP

    MDR report key: 16949903 · Received May 17, 2023

    Report

    Report Number
    3011270181-2023-00055
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Report Date
    June 7, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    MEA
    UDI-DI
    00193494001384
    PMA / PMN Number
    K162165
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT F113204 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE RETURNED PRODUCT WAS EVALUATED AND NO ISSUES WERE OBSERVED ON DEVICE. THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED FAILURE WAS NOT REPRODUCED IN LAB DURING SAMPLE EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2023 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 EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS 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.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 1=(B)(6). 2023 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 EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS (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

    FILL VOLUME: 500 ML. FLOW RATE: 8ML/HR, BOLUS 6ML EVERY 20 MIN. PROCEDURE: ANTERIOR CRUCIATE LIGAMENT/MEDIAL COLLATERAL LIGAMENT (ACL/MCL) REPAIR. CATHPLACE: UNKNOWN. INFUSION START TIME: (B)(6) 2023. INFUSION STOP TIME: (B)(6) 2023. IT WAS REPORTED, THE AMBIT PUMP ¿SEEMED TO RUN OUT OF MEDS EARLY FRIDAY MORNING¿... ¿AMBIT RAN OUT AT 5AM ON 24TH-HAD ONLY PUSHED BUTTON 2X FOR EXTRA MEDS¿. DURING A PHONE CALL THE PATIENT STATED, ¿THE PUMP INFUSED TOO QUICKLY BUT I AM NOT REALLY SURE...I GUESS THAT WAS HOW THE DOCTOR PROGRAMMED THE PUMP....I JUST EXPECTED THE PUMP TO LAST LONGER¿. SHE REPORTED, SHE BELIEVED THE PUMP WAS STARTED AROUND 5PM THE DAY OF HER SURGERY ON (B)(6) 2023. THE PATIENT DENIED EXPERIENCING ANY ADVERSE SIDE EFFECTS: NO DIZZINESS, RINGING OF EARS, BLURRED VISION, METALLIC TASTE IN MOUTH, ETC. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907313 AMBIT ELECTRONIC PAIN CONTROL PUMP ELECTRONIC INFUSION PUMPS & SYSTEMS MEA AVANOS MEDICAL INC. 220571 F113204 00193494001384

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female UNKNOWN MEDICATION