BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2950014 · Received February 8, 2013

    Report

    Report Number
    1416980-2013-03238
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 16, 2013
    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) - THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION RELATED TO THE CUSTOMER REPORTED CONDITION. THE TUBE MISLOADING DETECTION CIRCUITRY MALFUNCTIONED THUS RESULTING IN THE FORCE SENSING RESISTORS BEING DAMAGED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY IN THE PROCESS OF BEING EVALUATED ON-SITE AT THE FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:THE CUSTOMER REPORTED PROBLEM OF A FLOGARD INFUSION PUMP WITH AN "F-38" WAS CONFIRMED. SERVICE DETERMINED THAT THE CAUSE WAS DUE TO DAMAGED FORCE SENSING RESISTORS (FSRS), WHICH WERE REPLACED ONSITE AT THE FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLOGARD INFUSION PUMP WITH AN ALARM F38. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, PATIENT/USER INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53949 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1