BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3021705 · Received March 26, 2013

    Report

    Report Number
    1416980-2013-07293
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    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 CUSTOMER REPORTED CONDITION WAS CONFIRMED ON SITE. SERVICE DETERMINED THAT THE CAUSE WAS DUE TO A DAMAGED RIGHT FORCE SENSING RESISTOR (FSR). THE FSR WAS REPLACED ONSITE AT THE FACILITY, BY A FIELD SERVICE TECHNICIAN, IN ORDER TO RESOLVE THE ISSUE,

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLOGARD INFUSION PUMP WITH AN "F38 ALARM". IT IS UNKNOWN IF THIS EVENT OCCURRED DURING DELIVERY. PATIENT INVOLVEMENT IS UNKNOWN, HOWEVER THERE WAS NO REPORT OF PATIENT/USER INJURY NOR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123366 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1