BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    MDR report key: 1200444 · Received October 20, 2008

    Report

    Report Number
    6000001-2007-01978
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 22, 2006
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED IN ACCORDANCE WITH INSTRUCTION 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 18, 2007. EVALUATION SUMMARY: A BAXTER SERVICE TECHNICIAN EVALUATED THE DEVICE AND FOUND A BROKEN DOOR ON CHANNEL 1 AND A BROKEN DOOR LATCH ON CHANNEL 2. THE REPORTED CONDITION OF THE BROKEN DOOR ON CHANNEL 2 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 #2. 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