BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    MDR report key: 1240225 · Received November 24, 2008

    Report

    Report Number
    6000001-2007-06185
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    April 1, 2007
    Report Date
    April 12, 2007
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A BAXTER SERVICE TECHNICIAN EVALUATED THE DEVICE AND FOUND CRACKED DOOR ASSEMBLIES 1 AND 2. THE REPORTED CONDITION OF THE BROKEN DOOR ON CHANNEL 1 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.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A BROKEN DOOR #1 FOUND DURING BIO-MED TESTING. 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