BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3092201 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11237
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 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). EVALUATION SUMMARY: THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WITH AN F-38 FAILURE WHEN THE PUMP WAS TURNED ON WAS CONFIRMED AND REPAIRED BY BAXTER SERVICE PERSONNEL ONSITE AT THE CUSTOMER FACILITY. THE CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE DAMAGED FORCE-SENSING RESISTORS. THE FORCE-SENSING RESISTORS WERE REPLACED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLO-GARD INFUSION PUMP WITH AN F-38 FAILURE WHEN THE PUMP WAS TURNED ON. IT IS UNKNOWN WHEN, OR IN WHICH CARE AREA, THIS EVENT OCCURRED. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS NO PATIENT INVOLVEMENT, PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194400 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1