BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2162402 · Received July 14, 2011

    Report

    Report Number
    6000001-2011-11910
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED CONCLUSION CODE WAS ERRONEOUSLY OMITTED FROM THE INITIAL MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER AND PRODUCT CODE ARE NOT KNOWN, THEREFORE A 510K NUMBER CANNOT BE PROVIDED. THE DEVICE WILL NOT BE RETURNED TO BAXTER FOR EVALUATION. THE CUSTOMER RESET THE TIME AND THE DATE AND THE ERROR CODE 94 THEN STOPPED OCCURRING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4)

    Description of Event or Problem · 1

    THIS IS A REPORT OF A FLO-GARD PUMP WITH A FAILURE CODE 94, WHICH COULD HAVE CAUSED AN INTERRUPTION OF DELIVERY. IT IS UNKNOWN WHEN THE REPORTED CONDITION OCCURRED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION RELATED TO THIS EVENT. 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