BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3944846 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23310
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    SHARP CORPORATION OSAKA JAPAN
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FLOGARD INFUSION PUMP WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THIS IS AN ANCILLARY SERVICE EVENT. A VISUAL INSPECTION, ALARM LOG REVIEW AND A POWER ON SELF-TEST WERE PERFORMED. DURING THE VISUAL INSPECTION IT WAS IDENTIFIED THAT THE SAFETY CLAMP SHIM WAS OUT OF SPECIFICATION. THE CAUSE OF THE MALFUNCTION IS UNKNOWN. THE SAFETY CLAMP SHIM WAS REPLACED TO RESOLVE THE ISSUE. THE PUMP PASSED ALL SUBSEQUENT TESTING AND WAS RETURNED TO THE CUSTOMER IN GOOD WORKING ORDER. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING ON-SITE SERVICE, THE BAXTER SERVICE TECHNICIAN FOUND THAT THE FLOGARD INFUSION PUMP HAD AN OUT OF SPECIFICATION SAFETY CLAMP SHIM. THIS MALFUNCTION WAS IDENTIFIED DURING SERVICE; THEREFORE THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422215 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1