BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3153690 · Received June 8, 2013

    Report

    Report Number
    1416980-2013-14622
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS SERVICED ON-SITE. SAMPLE EVALUATION DISCOVERED AND CONFIRMED ALARM F-38. THE ROOT CAUSE OF THE ALARM WAS DETERMINED TO BE DEFECTIVE FORCE SENSING RESISTORS. TO RESOLVE THE ISSUE THE FORCE SENSING RESISTORS WERE REPLACED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP EXPERIENCED A MALFUNCTION. UPON SERVICING THE DEVICE, IT WAS DISCOVERED THAT THERE WAS AN ALARM F-38. IT WAS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256969 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1