BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 4120511 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33285
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THIS IS AN ANCILLARY SERVICE EVENT. DURING VISUAL INSPECTION OF THE DEVICE, IT WAS IDENTIFIED THAT THE SLIDE CLAMP SENSOR WAS DAMAGED. A POWER ON SELF TEST WAS PERFORMED ON THE DEVICE WITH NO ISSUES NOTED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. TO CORRECT THE CONDITION, THE SLIDE CLAMP SENSOR WAS REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING ON-SITE SERVICING, A FLOGARD INFUSION PUMP WAS FOUND TO HAVE A DAMAGED SLIDE CLAMP SENSOR. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600649 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1