BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    MDR report key: 1160447 · Received September 16, 2008

    Report

    Report Number
    6000001-2007-04812
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    February 1, 2007
    Report Date
    February 5, 2007
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 MAR 05 2007. EVALUATION SUMMARY:A BAXTER SERVICE TECHNICIAN EVALUTATED THE DEVICE AND FOUND BROKEN DOOR ASSEMBLIES 1 AND 2. THE REPORTED CONDITION OF THE BROKEN DOOR 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. 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. THE HOSPITAL REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6301 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1