BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3801006 · Received May 8, 2014

    Report

    Report Number
    1416980-2014-14846
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 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. VISUAL INSPECTION FOUND THE DEVICE TO BE IN GOOD PHYSICAL CONDITION. A REVIEW OF THE ALARM LOG DID NOT IDENTIFY ANYTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. THE DEVICE PASSED A POWER ON FUNCTIONAL TEST. AN INSERT SLIDE CLAMP ALARM OCCURRED DURING AN INFUSION TEST. THE REPORTED CONDITION OF THE DEVICE NOT FUNCTIONING WAS CONFIRMED AS THE INSERT SLIDE CLAMP ALARM. THE CAUSE OF THE INSERT SLIDE CLAMP ALARM WAS DETERMINED TO BE AN OUT OF CALIBRATION SAFETY SLIDE CLAMP ASSEMBLY. TO CORRECT THE CONDITION, THE SAFETY SLIDE CLAMP ASSEMBLY WAS RECALIBRATED. 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

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP DID NOT FUNCTION. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277800 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1