BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2141793 · Received June 27, 2011

    Report

    Report Number
    6000001-2011-08988
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    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

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP A FALSE AIR IN LINE ALARM ON THE LEFT SIDE WAS CONFIRMED AND DUPLICATED BY BAXTER SERVICE PERSONNEL. THE ROOT CAUSE OF THIS CONDITION WAS DETERMINED TO BE DAMAGE TO THE AIR SENSOR PRINTED CIRCUIT BOARD ON PUMP 1. THE AIR SENSOR ON PUMP 1 WAS REPLACED TO CORRECT THIS CONDITION. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT A FLOGARD PUMP WHICH EXPERIENCED A FALSE AIR IN LINE ALARM. THE EVENT OCCURRED IN THE GENERAL PATIENT WARD. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1