BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2933261 · Received January 29, 2013

    Report

    Report Number
    1416980-2013-02153
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: EVALUATION SUMMARY: THE REPORTED CONDITION OF "F-38 ALARM" WAS CONFIRMED DURING DEVICE EVALUATION. THE ROOT CAUSE WAS DETERMINED TO BE DUE TO DEFECTIVE TUBE MISLOADING SENSORS. THE TUBE MISLOADING SENSORS WERE REPLACED TO CORRECT THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4)-(CORRECTION TO INITIAL MDR) IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. (B)(4).

    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. 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

    IT WAS REPORTED TO BAXTER MEXICO THAT A FLOGARD INFUSION PUMP HAD AN 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
    38991 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1