BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3052983 · Received April 11, 2013

    Report

    Report Number
    1416980-2013-09039
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    October 24, 2012
    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 EXACT OCCURRENCE DATE OF THIS EVENT IS UNKNOWN. THE REPORTED CONDITION WAS CONFIRMED DURING DEVICE EVALUATION AS FAILURE CODE 38. THE SAMPLE WAS EVALUATED ONSITE BY A FIELD SERVICE TECHNICIAN. THE FORCE SENSING RESISTORS WERE FOUND TO BE DAMAGED. THE FSRS WERE REPLACED TO CORRECT THE REPORTED CONDITION. A SERVICE HISTORY WAS PERFORMED AND REVEALED NO PRIOR SERVICE FOR THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP THAT DID NOT WORK. UPON FURTHER INVESTIGATION BY THE QUALITY ENGINEER, THE REPORTED CONDITION WAS CONFIRMED AS FAILURE CODE 38. IT IS UNKNOWN AT WHICH PROCESS STEP OR AT WHICH CARE AREA THIS EVENT OCCURRED. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION RELATED TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155612 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1