BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PUMP

    MDR report key: 2514273 · Received March 28, 2012

    Report

    Report Number
    MW5024838
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    March 24, 2012
    Report Date
    March 28, 2012
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I-FLOW ON-Q PUMP WAS PLACED POST-OP FOR ABDOMINAL INCISION PAIN. THE FOLLOWING DAY, THE SURGEON FELT THAT THE ON-Q PUMP WITH BUPIVACAINE LOCAL INFUSION WAS NOT FUNCTIONING PROPERLY AND NOT DELIVERING THE PRESCRIBED LEVEL OF MEDICATION. A SECOND DEVICE WAS PREPARED BY PHARMACY AND THE DEVICE WAS REPLACED. THE MANUFACTURER HAS BEEN NOTIFIED AND WILL EVALUATE THE DEVICE. THE PATIENT WAS NOT INJURED IN ANY WAY AND HIS PAIN WAS CONTROLLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PUMP ON-Q PAIN PUMP MEB I-FLOW CORPORATION PM028A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR