BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER SOAKER

    MDR report key: 640070 · Received October 5, 2005

    Report

    Report Number
    2026095-2005-00076
    Event Type
    Other
    Date Received
    October 5, 2005
    Date of Event
    March 31, 2005
    Report Date
    October 3, 2005
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS CONNECTED TO AN ON-Q PUMP IN 8/05, TWO DAYS LATER AT APPROXIMATELY 10:45AM THE PATIENT BEGAN TO HAVE A SEIZURE AND WAS SUBSEQUENTLY DISCONNECTED FROM THE ON-Q PUMP AT THAT TIME. THE PATIENT WAS LATER TRANSPORTED TO ANOTHER HOSPITAL (ABBOTT NORTHWESTER-MPLS.) AND DURING THE TRANSPORT THE PATIENT EXPERIENCED ANOTHER SEIZURE, WHICH LASTED APPROXIMATELY ONE (1) HOUR. THE ON-Q PUMP WAS OBSERVED TO HAVE EMPTIED IN THIRTY-NINE (39) HOURS. ACCORDING TO THE CUSTOMER, THE PUMP IS TO BE RETURNED TO THE I-FLOW CORPORATION FOR INVESTIGATION WHETHER OR NOT THE PUMP MALFUNCTIONED AS A FAST FLOW. THE PATIENT'S CURRENT CONDITION IS STABLE AND BLOOD RESULTS FOR TOXICITY LEVELS CAME BACK NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER SOAKER INFUSION PUMP MEB I-FLOW CORP. PM026 4B2688

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other