BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 4141489 · Received October 4, 2014

    Report

    Report Number
    1416980-2014-34502
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 10, 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). DURING THE ALARM HISTORY REVIEW, IT WAS FOUND THAT THERE IS EVIDENCE THE INSERT SLIDE CLAMP ALARM RECORDED. AS A RESULT, REVIEW OF THE DEVICE LOGS VERIFIED THE REPORTED ISSUE. DURING VISUAL INSPECTION, A DAMAGED PUMP HEAD MODULE (PHM) WAS FOUND. DURING INFUSION TEST, THE DEVICE SHOWED INSERT SLIDE CLAMP ALARM. THE ASSIGNABLE CAUSE FOR THE REPORTED CONDITION WAS DETERMINED TO BE DAMAGED PHM. AS A RESULT, THE PHM WOULD NEED TO BE REPLACED. HOWEVER, THE DEVICE WAS SWAPPED, SINCE THE REPLACEMENT PHM WAS NOT IN STOCK. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP CHANNEL ONE (1) DOES ¿NOT FUNCTION¿. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621589 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1