BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2250514 · Received September 16, 2011

    Report

    Report Number
    6000001-2011-25064
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 30, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION CODE 63 IS BEING REMOVED. THE DOOR WAS REPAIRED TO ADDRESS THE CUSTOMER REPORTED CONDITION. HOWEVER, DUE TO AN ADDITIONAL CONDITION OF A BATTERY PROBLEM (REPORT # 6000001-2012-09476) AND THE DUAL CHANNEL FLO-GARD BATTERIES BEING ON BACK-ORDER; NO BATTERY REPAIRS HAVE BEEN MADE AND THE DEVICE HAS NOT YET BEEN RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A FLOGARD INFUSION PUMP WITH A DOOR DRAWER BROKEN WAS CONFIRMED DURING PRODUCT EVALUATION. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS DETERMINED TO BE A BROKEN DOOR. THE PUMP DOOR WAS REPLACED TO CORRECT THE REPORTED CONDITION. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. HOWEVER, DURING PREVIOUS SERVICE THE DOOR WAS REPLACED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLO-GARD INFUSION PUMP WITH "DOOR DRAWER BROKEN." ACCORDING TO THE FACILITY, THIS EVENT OCCURRED IN THE MEDICINE A AREA. THE FACILITY DID NOT HAVE INFORMATION REGARDING PATIENT INVOLVEMENT OR WHETHER THERE HAVE BEEN ANY REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION IN ASSOCIATION WITH 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