BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    MDR report key: 1162523 · Received September 18, 2008

    Report

    Report Number
    6000001-2007-04846
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    February 1, 2007
    Report Date
    February 7, 2007
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 MAR 06 2007. EVALUATION SUMMARY: THE PUMP WAS EVALUATED BY A BAXTER SERVICE TECHNICIAN. THE REPORTED CONDITION WAS NOT CONFIRMED. DURING SERVICE, THE TECHNICIAN DISCOVERED A BROKEN DOOR ASSEMBLY. 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 REPORTS THE DEVICE HAS A FAST FLOW RATE ON SIDE 2. WHEN THE DEVICE IS SET AT 150 IT DELIVERS 185. DETAILS WERE NOT AVAILABLE REGARDING THE SET UP OF THE INFUSION DEVICE. INFORMATION REGARDING WHETHER OR NOT THE DEVICE WAS IN USE ON A PATIENT WHEN THE PROBLEM WAS FOUND WAS ALSO NOT AVAILABLE AND NO ADDITIONAL CONTACT INFORMATION WAS PROVIDED. THE HOSPITAL REPRESENTATIVE STATED THEY HAVE NO RECORD OF ANY PATIENT INCIDENT INVOLVING THE PUMP SINCE THE LAST BAXTER SERVICE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1