BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3123806 · Received May 22, 2013

    Report

    Report Number
    1416980-2013-13103
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 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

    COMPLAINT NO: (B)(4). ADDITIONAL METHOD EVALUATION: THE CUSTOMER REPORTED CONDITION WAS CONFIRMED DURING ON-SITE DEVICE EVALUATION. THE FORCE SENSING RESISTORS WERE FOUND TO BE DAMAGED AND REPLACED TO RESOLVE THE REPORTED CONDITION. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FLOGARD INFUSION PUMP THAT ALARMED "38 FAILURE CODE IN CHANNEL A". IT IS UNKNOWN AT WHICH PROCESS STEP THIS EVENT OCCURRED. THERE WAS NO PATIENT INVOLVEMENT, PATIENT INJURY OR MEDICAL INTERVENTION RELATED TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225900 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1