BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2962199 · Received February 14, 2013

    Report

    Report Number
    1416980-2013-03801
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    December 28, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT DATE THE FAILURE OCCURRED IS UNKNOWN. THE REPORTED CONDITION OF "DOES NOT WORK" WAS CONFIRMED BY QUALITY ENGINEERING AS FAILURE 38. THE EVALUATION WAS PERFORMED ONSITE BY A BAXTER FIELD SERVICE TECHNICIAN. THE ROOT CAUSE OF THE 38 FAILURE WAS DUE TO DAMAGED FORCE SENSING RESISTORS (FSRS). THE FSRS WERE REPLACED TO RESOLVE THE REPORTED CONDITION. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A FLOGARD INFUSION PUMP "DOES NOT WORK." IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT; THEREFORE, NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64721 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1