BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3052776 · Received April 11, 2013

    Report

    Report Number
    1416980-2013-09031
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    October 1, 2012
    Report Date
    April 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED CONDITION WAS CONFIRMED DURING DEVICE EVALUATION AS FAILURE CODE 38. THE FORCE SENSING RESISTORS (FSRS) WERE FOUND TO BE DAMAGED. THE FSRS WERE REPLACED TO CORRECT THE REPORTED CONDITION. A SERVICE HISTORY REVIEW WAS PERFORMED AND REVEALED NO PRIOR SERVICE RELATED TO 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 THAT A FLOGARD INFUSION PUMP DID NOT WORK. UPON FURTHER INVESTIGATION, THE QUALITY ENGINEER CONFIRMED THE REPORTED CONDITION AS FAILURE CODE 38. IT IS UNKNOWN AT WHICH PROCESS STOP AND THE CARE AREA THAT THIS EVENT OCCURRED. THERE WAS NO REPORT OF 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
    154947 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1