BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2840104 · Received November 20, 2012

    Report

    Report Number
    1416980-2012-05655
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 28, 2012
    Report Date
    October 29, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED PROBLEM OF AN "INSERT SLIDE CLAMP" ALARM WAS CONFIRMED DURING EVALUATION. THE CAUSE OF THE PROBLEM WAS LOOSE SAFETY CLAMP SENSOR CONTACTS. THE SAFETY CLAMP SENSOR CONTACTS WERE CLEANED AND RE-SOLDERED TO FIX THE PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING EVALUATION. 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 REPORTED A COLLEAGUE/FLOGARD INFUSION PUMP WITH AN INSERT SIDE CLAMP ALARM. THE EVENT WAS REPORTED TO HAVE OCCURRED UPON POWER UP IN THE EMERGENCY ROOM. THERE WAS NO PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS 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