BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3122378 · Received May 21, 2013

    Report

    Report Number
    1416980-2013-13023
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED BY A BAXTER SERVICE TECHNICIAN AT THE CUSTOMER SITE. A POWER ON SELF TEST WAS PERFORMED WHICH IDENTIFIED THE F_38 ALARM. THE ROOT CAUSE WAS DETERMINED TO BE THE LEFT FORCE SENSING RESISTOR WAS OUT OF SPECIFICATION. THE LEFT FORCE SENSING RESISTOR WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP EXPERIENCED AN F-38 ALARM. THERE WAS NO PATIENT INVOLVEMENT. IT IS UNKNOWN WHEN IN THE PROCESS THIS OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223569 FLOGARD FRN FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1