BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN RELIEF SYSTEM

    MDR report key: 8879298 · Received August 8, 2019

    Report

    Report Number
    MW5088912
    Event Type
    Injury
    Date Received
    August 8, 2019
    Date of Event
    June 29, 2019
    Report Date
    August 6, 2019
    Manufacturer
    HALYARD / AVANOS MEDICAL, INC.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ON-Q PUMP PAIN RELIEF SYSTEM WAS INADVERTENTLY CONNECTED TO THE PT'S HICKMAN CATHETER THAN THE RIGHT CHEST ON-Q CATHETER. WE BELIEVE THIS ERROR WAS DUE IN PART TO THE ABILITY TO EASILY CONNECT THE TWO DEVICES. THE PT'S PAIN CONTROL WAS INITIALLY PROVIDED VIA EPIDURAL CATHETER; HOWEVER, FOLLOWING REMOVAL OF THE EPIDURAL CATHETER, THE PLAN WAS TO BEGIN CONTINUOUS PAIN RELIEF VIA THE ON-Q PAIN RELIEF SYSTEM. THE ON-Q CATHETER WAS PRESENT BUT NOT VISIBLE TO THE NURSE AND HAD NOT BEEN USED UP UNTIL THIS POINT. THE NURSE WAS UNFAMILIAR WITH ON-Q PUMPS AND ASSUMED THE ON-Q PAIN RELIEF SYSTEM SHOULD BE CONNECTED TO THE HICKMAN CATHETER. THE PT RECEIVED ROPIVACAINE VIA THE HICKMAN TIMES FOUR HOURS BEFORE THE ERROR WAS IDENTIFIED AND CORRECTED. THERE WAS NO ADVERSE OUTCOME AS A RESULT OF THIS EVENT. OUR CONCERN WAS THE ABILITY TO EASILY CONNECT THE TWO DEVICES. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671105 ON-Q PAIN RELIEF SYSTEM PUMP, INFUSION, ELASTOMERIC MEB HALYARD / AVANOS MEDICAL, INC. CB0004 0002968472

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR