BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2113533 · Received June 3, 2011

    Report

    Report Number
    6000001-2011-07076
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF LOW BATTERY ALARM WAS CONFIRMED THROUGH EVALUATION AND WAS FOUND TO BE DUE TO DEPLETED MAIN BATTERY. THE MAIN BATTERY WAS REPLACED TO CORRECT THE CONDITION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A BAXTER SERVICE TECHNICIAN REPORTED FINDING A FLO-GARD INFUSION PUMP WITH A LOW BATTERY ALARM OCCURRING DURING STEP 9.15.4 OF THE BATTERY OPERATION TEST AND INTERRUPTING DELIVERY . THIS EVENT OCCURRED DURING PRODUCT EVALUATION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1