BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 4251771 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40666
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 22, 2014
    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

    COMPLAINT NO: CMPLNT-(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. A VISUAL INSPECTION, ALARM LOG REVIEW, AND FUNCTIONAL TESTING WERE PERFORMED. NO ALARMS, MALFUNCTIONS OR ABNORMALITIES WERE IDENTIFIED DURING THE EVALUATION OF THE DEVICE. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLO-GARD INFUSION PUMP PRESENTED AN F-38 ALARM. IT WAS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736927 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1