BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3033156 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08245
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED PROBLEM OF A FLOGARD INFUSION PUMP WITH AN "ALARM 38" WAS CONFIRMED IN THE SAMPLE EVALUATION AND EVENT HISTORY LOG REVIEW TASK. SERVICE DETERMINED THAT THE CAUSE WAS DAMAGED FORCE SENSING RESISTORS. THE RESISTORS WERE REPLACED ONSITE AT THE FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN TO RESOLVE THE ISSUE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLOGARD INFUSION PUMP THAT "HAS THE ALARM 38 WHEN IT IS TURN ON". 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
    135747 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1