BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11628873 · Received April 7, 2021

    Report

    Report Number
    2026095-2021-00051
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    December 1, 2020
    Report Date
    May 28, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    MEB
    UDI-DI
    00193494134747
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. THE PUMP WAS RECEIVED PARTIALLY FILLED, WITH THE PINCH CLAMP CLOSED. THE SELECT-A FLOW WAS SET TO 8. THERE WAS A FILTER ATTACHED AT THE DISTAL LUER. THE BOLUS INDICATOR WAS AT EMPTY AND THE BUTTON APPEARED TO BE IN THE UP POSITION. DURING TESTING, THE REPORTED FAILURE OF THE BOLUS BUTTON STUCK DOWN WAS NOT OBSERVED. AT EACH DISPENSING, THE BOLUS BUTTON LATCHED WHEN DEPRESSED AND POPPED BACK UP UPON COMPLETION. ROOT CAUSE WAS DETERMINED TO BE INCORRECT USE. USE REVIEW INDICATED THE PUMP MAY NOT HAVE BEEN PRIMED IN THE CORRECT SEQUENCE. ALL INFORMATION REASONABLY KNOWN AS OF 27 MAY 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)(6). 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 DEVICE HISTORY RECORD FOR LOT 2995275 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED. THE INVESTIGATION REMAINS IN PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 24 MAY 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 · 1

    A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. ALL INFORMATION REASONABLY KNOWN AS OF 05 APR 2021 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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).

    Description of Event or Problem · 1

    FILL VOLUME: 550 ML. FLOW RATE: 8 ML/HR. PROCEDURE: TOTAL KNEE REPLACEMENT. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE BOLUS BUTTON ON THE PUMP "DID NOT POP BACK UP AFTER BEING PRESSED TO ADMINISTER A 5ML BOLUS. THE RED FILL LINE INDICATOR HAS NOT MOVED FROM THE BOTTOM TO THE TOP OF THE BOLUS." THE ANESTHESIOLOGIST DECIDED TO CLAMP THE PUMP AND REMOVE IT FROM THE PATIENT. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 30-MAR-2021 INDICATED THE PRIMING TAB WAS REMOVED PRIOR TO PATIENT USE AND THE PRIMING KEY DID NOT BREAK UPON REMOVAL. THIS INCIDENT WAS THE FIRST TIME THE BOLUS BUTTON WAS DEPRESSED. FILLING PROCEDURE FOR THIS SPECIFIC OCCASION IS UNKNOWN. THE ANESTHESIOLOGIST WAS ATTACHING THE PUMP TO AN ALTERNATIVE BRANDED NERVE CATHETER AND A FILTER MAY HAVE BEEN ATTACHED TO THE CATHETER BEFORE THE CATHETER WAS ATTACHED TO THE PUMP. PUMP WAS FILLED WITH 0.2% ROPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526432 ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND ELASTOMERIC - COMBO MEB AVANOS MEDICAL INC. CB006 2995275 00193494134747

    Patients

    Seq Age Sex Outcome Treatment
    1 0.2% ROPIVACAINE