BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 2003261 · Received February 28, 2011

    Report

    Report Number
    6000001-2011-01416
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A FLO-GARD INFUSION PUMP WHICH EXPERIENCED AN FALSE OCCLUSION ALARM. THIS DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION DID NOT CONFIRM THE REPORTED CONDITION OF AN OCCLUSION ALARM. THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE PUMP PASSED ALL TESTING. NO ACTION WAS NECESSARY TO REPAIR THE REPORTED CONDITION. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLO-GARD INFUSION PUMP WHICH EXPERIENCED A FALSE OCCLUSION ALARM IN THE MEDICAL SURGERY DEPARTMENT. IT IS UNKNOWN WHEN OR AT WHAT POINT IN THE PROCESS THIS CONDITION OCCURRED. THERE WAS NO PATIENT INVOLVEMENT. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION OF THIS DEVICE IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1