BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2120917 · Received June 12, 2011

    Report

    Report Number
    6000001-2011-07550
    Event Type
    Malfunction
    Date Received
    June 12, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF FALSE AIR ALARM WAS CONFIRMED AND FOUND TO BE DUE TO A DAMAGED AIR SENSOR ON PUMP P1. THE P1 AIR SENSOR ASSEMBLY WAS REPLACED AND CALIBRATED TO CORRECT THE CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A BAXTER SERVICE TECHNICIAN REPORTED FINDING A FLO-GARD INFUSION PUMP WITH A FALSE AIR ALARM ON PUMP ONE DURING TESTING. 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