BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR PUMP

    MDR report key: 1062191 · Received June 13, 2008

    Report

    Report Number
    6000001-2008-00374
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 29, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    PMA / PMN Number
    K926385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT YET BEEN RECEIVED FOR EVAL. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVAL, OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REP REPORTED A PUMP THAT RUNS AND SHUTS OFF. INFO WAS NOT PROVIDED REGARDING WHETHER OR NOT THE PROBLEM OCCURRED DURING AN INFUSION. NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED. ALTHOUGH BAXTER ATTEMPTED TO OBTAIN INFO, DETAILS WERE NOT AVAILABLE REGARDING ADDITIONAL CONTACT INFO. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP 80FRN FRN BAXTER HEALTHCARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1