BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAIN PUMP

    MDR report key: 1880513 · Received October 15, 2010

    Report

    Report Number
    2026095-2010-00256
    Event Type
    Other
    Date Received
    October 15, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. THE SAMPLE WILL BE EVALUATED WHEN RECEIVED AND A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    FLOWED TOO FAST. PLACED ON (B)(6) 2010. PUMP WAS WEIGHED AFTER 3.5 HOURS (310 G) AND AFTER 17.5 HOURS (266 G), AND CALCULATIONS INDICATE IT INFUSED TOO MUCH DURING THAT TIME (44 G). THEY BELIEVE IT SHOULD HAVE INFUSED ONLY 30.1 G AT MOST. PUMP REMOVED FROM PT. NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAIN PUMP ELASTOMERIC PUMP MEB I-FLOW CORP. PS6503 992800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK