BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2221345 · Received August 24, 2011

    Report

    Report Number
    6000001-2011-20493
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BAXTER HEALTHCARE-SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH CURRENT CABLE WAS CONFIRMED DURING PRODUCT EVALUATION. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS DETERMINED TO BE BROKEN AC POWER CORD. HOWEVER, NO REPAIRS HAVE BEEN MADE AND THE DEVICE WAS RETURNED UNREPAIRED TO THE CUSTOMER. ADDITIONAL INFORMATION: THE DEVICE HISTORY RECORD REVIEW SHOWS DATA CARD DISCARDED PER DOC. 20J RETENTION PERIOD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT A FLOGARD PUMP IN WHICH THE ALTERNATING CURRENT CABLE WAS BROKEN. THIS CONDITION HAS THE POTENTIAL TO CAUSE AN INTERRUPTION OF DELIVERY. THE EVENT OCCURRED UPON POWER UP IN THE EMERGENCY ROOM. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. THERE IS NO FURTHER COMPLAINT INFORMATION 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