BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND

    MDR report key: 12422807 · Received September 3, 2021

    Report

    Report Number
    2026095-2021-00090
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 12, 2021
    Report Date
    October 29, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    MEB
    UDI-DI
    00193494134839
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT 30070743 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE INVESTIGATION REMAINS IN PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 24 SEP 2021 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

    A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 0

    ONE USED DEVICE WAS RETURNED FOR EVALUATION. TESTING OF THE PUMP REVEALED THAT IT MET SPECIFICATIONS FOR ALL SELECTABLE FLOW RATES. THE REPORTED EVENT COULD NOT BE DUPLICATED IN THE LAB. COMPLAINT COULD NOT BE CONFIRMED AS REPORTED. ROOT CAUSE WAS NOT DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 28 OCT 2021 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 06-SEP-2021 INDICATED THAT IT "SEEMS THAT THE BOLUS ON-Q PUMP WAS NOT USED ACCORDINGLY."

    Description of Event or Problem · 0

    FILL VOLUME: 400 ML, FLOW RATE: 4 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE PUMP EMPTIED IN LESS THAN 24 HOURS WITHOUT USE OF THE BOLUS BUTTON. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 17-AUG-2021 INDICATED THE PUMP WAS FILLED WITH 400ML ROPIVACAINE. THE PATIENT IS A PALLIATIVE CARE PATIENT (NON-VERBAL). THE NURSE WAS EXPERIENCED AND THE PUMP WAS ON THE PATIENT'S BED DURING DELIVERY OF THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321716 ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND ELASTOMERIC - COMBO MEB AVANOS MEDICAL INC. CBI006 30070743 00193494134839

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR ROPIVACAINE 2MG/ML