BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSO.R. PUMP

    MDR report key: 1212990 · Received October 29, 2008

    Report

    Report Number
    6000001-2007-81062
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    July 5, 2007
    Report Date
    July 5, 2007
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    PMA / PMN Number
    K926385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM THE FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA JULY 31, 2007. EVALUATION SUMMARY: THE REPOPRTED PROBLEM OF OVERINFUSION, WAS NOT CONFIRMED. THE INFUSION PUMP WAS TESTED FOR FLOW ACCURACY. THE RESULTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED AND OVERINFUSIONON THE PUMP. THE REPRESENTATIVE STATED "THE FLOW RATE IS NOT CORRECT, IT OS OFF, PAST 3%". THIS WAS FOUND DURING BIOMED TESTING, WITH NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSO.R. PUMP 80FRN FRN BAXTER HEALTHCARE (SG) N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1