BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3020114 · Received March 25, 2013

    Report

    Report Number
    1416980-2013-07176
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    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). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. THIS DEVICE WAS EVALUATED ON-SITE BY A BAXTER FIELD SERVICE TECHNICIAN. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED PROBLEM OF "ALARM 27" WAS CONFIRMED IN THE SAMPLE EVALUATION AND EVENT HISTORY LOG REVIEW TASK. SERVICE DETERMINED THAT THE CAUSE WAS DUE TO A DAMAGED SAFETY SLIDE CLAMP ASSEMBLY. THE SAFETY SLIDE CLAMP ASSEMBLY WAS REPLACED TO RESOLVE THE ISSUE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLOGARD INFUSION PUMP THAT "HAS THE ALARM 27". IT IS UNKNOWN IF THIS EVENT OCCURRED DURING DELIVERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORT OF PATIENT/USER INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121790 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1