BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1161703 · Received September 17, 2008

    Report

    Report Number
    6000001-2007-00574
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 12, 2006
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON JAN 05 2007. THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. WHEN THE PUMP IS RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A BROKEN DOOR LATCH ASSEMBLY. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE PROBLEM OCCURRED DURING A PATIENT INFUSION. ALTHOUGH BAXTER ATTEMPTED TO OBTAIN INFORMATION, DETAILS WERE NOT AVAILABLE REGARDING ADDITIONAL CONTACT INFORMATION. ACCORDING TO THE FACILITY REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1