BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1170169 · Received September 24, 2008

    Report

    Report Number
    6000001-2007-00919
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 15, 2006
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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 09, 2007. EVALUATION SUMMARY:A BAXTER SERVICE TECHNICIAN EVALUATED THE PUMP AND FOUND A BROKEN DOOR. THE REPORTED CONDITION WAS CONFIRMED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A BROKEN DOOR LATCH. 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 (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1