BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIT ELECTRONIC PAIN CONTROL PUMP

    MDR report key: 10683321 · Received October 15, 2020

    Report

    Report Number
    1722214-2020-00007
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Report Date
    December 28, 2020
    Manufacturer
    SUMMIT MEDICAL PRODUCTS, INC.
    Product Code
    FRN
    UDI-DI
    00857595005824
    PMA / PMN Number
    K162165
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 14-NOV-2020 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, INC. 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

    CORRECTION: UDI NUMBER IN D4 HAS BEEN CORRECTED. THE DEVICE HISTORY RECORD (DHR) FOR THE REPORTED SERIAL NUMBER (B)(6) IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE DHR REVIEW PERFORMED FOR (B)(6) NOTED THE PUMP WAS MANUFACTURED AS A PART OF LOT E932904. THE SAMPLE DEVICE WAS EVALUATED. THE PUMP AND CASSETTE PASSED ALL FUNCTIONAL TESTING. A ROOT CAUSE FOR THE REACTION THAT WAS RELATED TO THE PUMP FAILURE COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 23-DEC-2020 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, INC. 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 · 1

    THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 15-OCT-2020 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, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP (B)(4).

    Description of Event or Problem · 1

    FILL VOLUME: 1000 ML , FLOW RATE: SETTINGS: LIMIT SET: 14ML DOSE: 8ML , DOSE TIME: 1 HOUR BOLUS: 6ML LOCKOUT TIME: 15-MINUTES , PROCEDURE: OUT-PATIENT TOTAL KNEE ARTHROSCOPY, CATHPLACE: UNKNOWN. IT WAS REPORTED THE CLINICIANS CONNECTED THE PUMP TO THE PATIENT AFTER REVIEWING THE PRE-PROGRAMED SETTINGS. AFTER PUSHING THE START BUTTON, THE CLINICIANS PUSHED FOR A BOLUS. AFTER SOME TIME ELAPSED (ABOUT AN HOUR), THE NURSE WENT TO INSTRUCT THE PATIENT AND FAMILY ON THE BOLUS AND THE PUMP BEGAN TO INFUSE. THE VOLUME INFUSED NOTED IT WAS 19.5ML AND THE NURSE STOPPED THE DEVICE, THINKING IT WAS INFUSING TOO MUCH. THEY REMOVED THE PUMP, AND REPLACED IT WITH ANOTHER THAT FUNCTIONED FINE. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148338 AMBIT ELECTRONIC PAIN CONTROL PUMP ELECTRONIC INFUSION PUMPS & SYSTEMS FRN SUMMIT MEDICAL PRODUCTS, INC. 220527 E932904 00857595005824

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR 0.125% MARCAINE