BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2220911 · Received August 23, 2011

    Report

    Report Number
    6000001-2011-20434
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BAXTER HEALTHCARE-SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WITH DIAGNOSTIC FAILURE CODE 38 WAS CONFIRMED AND DUPLICATED BY BAXTER SERVICE PERSONNEL. THE ROOT CAUSE OF THIS CONDITION WAS DETERMINED TO BE A MALFUNCTION IN THE MISLOAD DETECTION CIRCUIT. BOTH FORCE-SENSING RESISTORS ON PUMP TWO WERE REPLACED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT A FLOGARD PUMP IN WHICH FAILURE CODE 38 OCCURRED. THIS CONDITION HAS THE POTENTIAL TO CAUSE AN INTERRUPTION OF DELIVERY. THERE WAS NO PATIENT INVOLVEMENT. THE EVENT OCCURRED DURING SET-UP. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1