BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 2051019 · Received April 12, 2011

    Report

    Report Number
    6000001-2011-02787
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED PROBLEM WAS CONFIRMED AND REPRODUCED BY SERVICE. NO CAUSE WAS IDENTIFIED FOR THE REPORTED PROBLEM BECAUSE IT IS NORMAL THAT THE DEVICE ALARMED AN AIR ALARM WHEN THE PUMP STARTS WITHOUT A SET LINE LOADED INTO THE PUMPHEAD, NO REPAIR NEEDED. (B)(4). A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. (B)(4). BAXTER WILL CONTINUE TO MONITOR AND REPORT ON DEATH AND SERIOUS INJURY EVENTS AND FOLLOW EXISTING ESCALATION PROCESSES TO ASSESS THE IMPACT ON PATIENT SAFETY.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLO-GARD INFUSION PUMP WHICH EXPERIENCED AN AIR IN LINE ALARM UPON POWER-UP BEFORE THE TUBING HAD BEEN LOADED IN THE PEDIATRICS DEPARTMENT. THIS ALARM WAS A FALSE AIR IN LINE ALARM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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