BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1231047 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-88452
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    May 1, 2007
    Report Date
    May 2, 2007
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE FACILITY REPRESENTATIVE REPORTED A FALSE OPEN DOOR ALARM. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE FAILURE OCCURRED DURING A PATIENT INFUSION. THE PUMP WAS EVALUATED BY A BAXTER SERVICE TECHNICIAN. INSPECTION OF THE DEVICE FOUND THAT THE OPEN DOOR ALARM WAS CAUSED BY A BROKEN DOOR LATCH. 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 DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE BY BAXTER, A BROKEN DOOR LATCH WAS FOUND. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION OR CONTACT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE (SG)

    Patients

    Seq Age Sex Outcome Treatment
    1