BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3021328 · Received March 26, 2013

    Report

    Report Number
    1416980-2013-07262
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 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

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION OF AN F38 ALARM. THIS DEVICE WAS EVALUATED ON-SITE BY A BAXTER FIELD SERVICE TECHNICIAN. UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED PROBLEM "ALARM 38" WAS CONFIRMED DURING THE SAMPLE EVALUATION. THE CAUSE OF THE CONDITION WAS THE TUBE MISLOADING SENSOR. THE TUBE MISLOADING SENSOR WAS REPLACED TO RESOLVE THE CUSTOMER REPORTED PROBLEM. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A FACILITY THAT AN ALARM 38 OCCURRED WITH A FLOGARD INFUSION PUMP . IT IS UNKNOWN IF THIS EVENT OCCURRED DURING DELIVERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORT OF PATIENT/USER INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123553 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1