BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q

    MDR report key: 6654372 · Received June 20, 2017

    Report

    Report Number
    6654372
    Event Type
    Malfunction
    Date Received
    June 20, 2017
    Date of Event
    April 5, 2017
    Report Date
    May 11, 2017
    Manufacturer
    HALYARD HEALTH, INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RECENTLY IN OUR ORGANIZATION, A PATIENT RECOVERING FROM AN ORTHOPEDIC PROCEDURE CONNECTED HIS ON-Q PUMP TO HIS PERIPHERAL IV. FORTUNATELY THIS WAS IMMEDIATELY IDENTIFIED BY THE PATIENT'S RN. ANESTHESIA WAS NOTIFIED, THE PATIENT WAS MONITORED, AND THE ON-Q PUMP WAS DISCONTINUED. MANUFACTURER RESPONSE FOR PAIN RELIEF SYSTEM, ON-Q PUMP (PER SITE REPORTER). CURRENTLY THERE IS NOT AN ALTERNATIVE FOR THE LUER CONNECTOR'S COMPATIBILITY WITH STANDARD IV TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435853 ON-Q PUMP, INFUSION, ELASTOMERIC MEB HALYARD HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR