BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2992227 · Received March 7, 2013

    Report

    Report Number
    1416980-2013-05463
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER'S REPORTED PROBLEM OF A FLOGARD INFUSION PUMP WITH AN F-38 ALARM WAS CONFIRMED IN THE SAMPLE EVALUATION. THE CAUSE OF THE PROBLEM WAS RIGHT SENSORS OF CHANNEL 1 AND 2 WERE DAMAGED. THE TUBE MISLOADING SENSORS RIGHT OF CHANNEL 1 AND 2 WERE REPLACED ONSITE AT THE FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLOGARD INFUSION PUMP THAT PRESENTED "ALARM 38." IT IS UNKNOWN IF THIS EVENT OCCURRED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, PATIENT/USER INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96837 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1