BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2150419 · Received July 6, 2011

    Report

    Report Number
    6000001-2011-10453
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 16, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WITH NO ALARM FOR END OF BAG WAS NOT CONFIRMED OR DUPLICATED BY BAXTER SERVICE PERSONNEL. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, NO CAUSE COULD BE DETERMINED AND NO REPAIRS WERE MADE. A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED, AS THE SUPPLIED SERIAL NUMBER IS NOT VALID FOR THE (B)(4) MANUFACTURING PLANT. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A PHARMACY TECHNICIAN (PT) REPORTED A FLO-GARD INFUSION PUMP WHICH DID NOT ALARM FOR END OF BAG. IT IS UNKNOWN WHEN, OR IN WHICH CARE AREA, THIS EVENT OCCURRED. THIS CONDITION OCCURRED AT THE END OF THE INFUSION. ACCORDING TO THE PT, THE PATIENT WHO REPORTEDLY "PAYS CLOSE ATTENTION TO THE DEVICE, WATCHED THE DEVICE COME TO THE END OF INFUSION; THE BAG EMPTIED; THE TUBING SUBSEQUENTLY WAS COLLAPSING; AND THE DEVICE CONTINUED TO INFUSE WITH NO ALARMS OCCURRING." THE PATIENT REPORTEDLY STOPPED THE DEVICE AS SOON AS THE PROBLEM WAS NOTED "BEFORE ANYTHING COULD OCCUR." THE DRUG THAT WAS BEING INFUSED IS CURRENTLY NOT KNOWN. THE PT STATED THAT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION IN REGARDS TO THIS OCCURRENCE. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1