BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1024102 · Received April 5, 2008

    Report

    Report Number
    6000001-2007-04679
    Event Type
    Malfunction
    Date Received
    April 5, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 31, 2007
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTS A DEVICE WITH A BROKEN DOOR, FOUND DURING BIOMED TESTING. THE HOSPITAL REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF ANY PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1