BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP 2M8063,

    MDR report key: 2000164 · Received February 24, 2011

    Report

    Report Number
    6000001-2011-01317
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    December 15, 2010
    Report Date
    February 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS NOT CONFIRMED AND NOT DUPLICATED THROUGH EVALUATION. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED AT THIS TIME. THE DEVICE WILL NOT BE REPAIRED AT THIS TIME SINCE IT IS A STAY-IN UNIT. ADDITIONAL: A SERVICE HISTORY REVIEW HAS BEEN PERFORMED AND THE DEVICE HAS NOT BEEN PREVIOUSLY SERVICED FOR 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.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A FLO-GARD INFUSION PUMP THAT "STOPS WORKING AND MAKES LOUD BEEPING NOISE". THE DEVICE TURNED ITSELF OFF WHILE RUNNING AN OVERNIGHT TEST IN THE LAB. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP 2M8063, PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1