BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3070871 · Received April 22, 2013

    Report

    Report Number
    1416980-2013-09993
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 24, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PROBLEM OF "PUMP DOES NOT FUNCTION" WAS CONFIRMED VIA SAMPLE EVALUATION AS ALARM F38. THE CAUSE WAS DETERMINED TO BE DAMAGED FORCE SENSING RESISTORS. THE FORCE SENSING RESISTORS WERE REPLACED TO FIX THE PROBLEM. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THERE WERE NOT PREVIOUSLY REPORTED "PROBLEMS THAT WERE SAME AS OR SIMILAR TO THE EVENT REPORTED".

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER THAT A FLOGARD PUMP WAS NOT FUNCTIONING. PATIENT INVOLVEMENT IS UNKNOWN AT THIS TIME, ALTHOUGH NO PATIENT INJURY WAS REPORTED AT THE TIME OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172101 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1