BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2221294 · Received August 24, 2011

    Report

    Report Number
    6000001-2011-20492
    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 FLO GARD INFUSION PUMP WHERE THE SAFETY CLAMP DOES NOT FIT WAS CONFIRMED DURING PRODUCT EVALUATION. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS DETERMINED TO BE CORROSION AND DIRT ON THE SAFETY SLIDE CLAMP SENSOR. APPROPRIATE ACTION WAS TAKEN TO CORRECT THE REPORTED PROBLEM BY CLEANING AND RESOLDERING THE SAFETY SLIDE CLAMP SENSOR CONTACTS.

    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 SAFETY CLAMP DOES NOT FIT. THIS CONDITION HAS THE POTENTIAL TO CAUSE AN INTERRUPTION OF DELIVERY. THE EVENT OCCURRED UPON POWER UP IN THE GENERAL PATIENT WARD. 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