BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER SOAKER

    MDR report key: 1583370 · Received January 14, 2010

    Report

    Report Number
    2026095-2010-00003
    Event Type
    Other
    Date Received
    January 14, 2010
    Date of Event
    January 1, 2009
    Report Date
    December 17, 2009
    Manufacturer
    I-FLOW CORPORATION
    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

    THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. INFO RECEIVED FOR THIS COMPLAINT WAS INCOMPLETE. THE ACTUAL INFUSION TIMES AND THE ACTUAL SAMPLE WERE NOT AVAILABLE FROM THE CUSTOMER. NO ADVERSE EVENT WAS REPORTED. NO DETERMINATION CAN BE MADE AS TO WHAT MAY HAVE OCCURRED WITH THIS DEVICE. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD AND THE LOT HISTORY CANNOT BE REVIEWED. IF ADDITIONAL INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    PUMP IS FLOWING TOO FAST. AFTER 2 DAYS, IT WAS EMPTY. IT WAS REPORTED THAT PUMP WAS PLACED WITH NEONATE PT WHOSE TEMP IS 33 DEGREES C. (INSTEAD OF 31 DEGREES C).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER SOAKER INFUSION PUMP MEB I-FLOW CORPORATION PS2501 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other