BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW

    MDR report key: 16111323 · Received January 6, 2023

    Report

    Report Number
    16111323
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    December 10, 2022
    Report Date
    January 3, 2023
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    MEB
    UDI-DI
    00193494134723
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENT1: ON-Q PUMP RAN OUT IN 30 HOURS INSTEAD OF EXPECTED 55 HOURS. PUMP HAS BEEN RETURNED AND IS CURRENTLY UNDER EVALUATION. DIAL WAS SET AT APPROPRIATE PRESCRIBED RATE OF 10 ML/HR. CLAMP WAS OPEN AND ALL APPEARED TO BE VISIBLY INTACT, AS WOULD BE EXPECTED. PATIENT REPORTED NAUSEA AND BALANCE ISSUES, WHICH IS THOUGHT TO BE LIKELY A SIDE EFFECT OF THE FASTER INFUSION. EVENT2: PATIENT'S ON-Q PUMP WAS STILL HALF FULL WHEN IT WAS TIME TO BE REMOVED. RATE DIAL SET AT PROGRAMMED RATE. INFUSION CLAMP WAS OPEN. PATIENT INSTRUCTED TO BRING CATHETER AND ON-Q PUMP WITH HIM FOR RETURN VISIT. EVENT3: I HAVE A PATIENT THAT WENT HOME YESTERDAY WITH AN ON-Q AND THE PUMP IS NOT INFUSING. THE PUMP HAS BEEN CONNECTED FOR 24 HOURS AND THE PATIENT SAYS IT HAS NOT DECREASED IN SIZE AT ALL. RATE DIAL VERIFIED. PATIENT INSTRUCTED TO BRING PUMP BACK FOR RETURN VISIT.

    Description of Event or Problem · 0

    EVENT1: ON-Q PUMP RAN OUT IN 30 HOURS INSTEAD OF EXPECTED 55 HOURS. PUMP HAS BEEN RETURNED AND IS CURRENTLY UNDER EVALUATION. DIAL WAS SET AT APPROPRIATE PRESCRIBED RATE OF 10 ML/HR. CLAMP WAS OPEN AND ALL APPEARED TO BE VISIBLY INTACT, AS WOULD BE EXPECTED. PATIENT REPORTED NAUSEA AND BALANCE ISSUES, WHICH IS THOUGHT TO BE LIKELY A SIDE EFFECT OF THE FASTER INFUSION. EVENT2: PATIENT'S ON-Q PUMP WAS STILL HALF FULL WHEN IT WAS TIME TO BE REMOVED. RATE DIAL SET AT PROGRAMMED RATE. INFUSION CLAMP WAS OPEN. PATIENT INSTRUCTED TO BRING CATHETER AND ON-Q PUMP WITH HIM FOR RETURN VISIT. EVENT3: I HAVE A PATIENT THAT WENT HOME YESTERDAY WITH AN ON-Q AND THE PUMP IS NOT INFUSING. THE PUMP HAS BEEN CONNECTED FOR 24 HOURS AND THE PATIENT SAYS IT HAS NOT DECREASED IN SIZE AT ALL. RATE DIAL VERIFIED. PATIENT INSTRUCTED TO BRING PUMP BACK FOR RETURN VISIT.

    Description of Event or Problem · 0

    EVENT1: ON-Q PUMP RAN OUT IN 30 HOURS INSTEAD OF EXPECTED 55 HOURS. PUMP HAS BEEN RETURNED AND IS CURRENTLY UNDER EVALUATION. DIAL WAS SET AT APPROPRIATE PRESCRIBED RATE OF 10 ML/HR. CLAMP WAS OPEN AND ALL APPEARED TO BE VISIBLY INTACT, AS WOULD BE EXPECTED. PATIENT REPORTED NAUSEA AND BALANCE ISSUES, WHICH IS THOUGHT TO BE LIKELY A SIDE EFFECT OF THE FASTER INFUSION. EVENT2: PATIENT'S ON-Q PUMP WAS STILL HALF FULL WHEN IT WAS TIME TO BE REMOVED. RATE DIAL SET AT PROGRAMMED RATE. INFUSION CLAMP WAS OPEN. PATIENT INSTRUCTED TO BRING CATHETER AND ON-Q PUMP WITH HIM FOR RETURN VISIT. EVENT3: I HAVE A PATIENT THAT WENT HOME YESTERDAY WITH AN ON-Q AND THE PUMP IS NOT INFUSING. THE PUMP HAS BEEN CONNECTED FOR 24 HOURS AND THE PATIENT SAYS IT HAS NOT DECREASED IN SIZE AT ALL. RATE DIAL VERIFIED. PATIENT INSTRUCTED TO BRING PUMP BACK FOR RETURN VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391976 ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW PUMP, INFUSION, ELASTOMERIC MEB AVANOS MEDICAL, INC. 13472 30179495 00193494134723

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown