BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2880440 · Received December 19, 2012

    Report

    Report Number
    1416980-2012-07768
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A F-38 ALARM WAS CONFIRMED DURING EVALUATION. THE ASSIGNABLE CAUSE WAS DUE TO DEFECTIVE FORCE SENSING RESISTORS (FSR). THE FSRS WERE REPLACED TO CORRECT THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED. 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. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP.

    Description of Event or Problem · 1

    BAXTER (B)(4) REPORTED A FLOGARD INFUSION PUMP WITH A F-38 ALARM. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT; THEREFORE, NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1