BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3230364 · Received July 16, 2013

    Report

    Report Number
    1416980-2013-18700
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 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 FLOGARD INFUSION PUMP WAS EVALUATED ON-SITE. DURING VISUAL INSPECTION AND AN ALARM LOG REVIEW, IT WAS DETERMINED THAT ALARM 94 WAS THE MORE SPECIFIC PROBLEM. THE CAUSE OF THE MALFUNCTION WAS A LOW MAIN BATTERY. THE MAIN BATTERY WAS REPLACED TO FIX THE REPORTED MALFUNCTION. THE PUMP PASSED ALL TESTS AND WAS RETURNED TO THE CUSTOMER IN GOOD WORKING ORDER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION DID NOT FUNCTION. THE PROCESS STEP IN WHICH THIS MALFUNCTION WAS IDENTIFIED IS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327863 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1