BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2924151 · Received January 22, 2013

    Report

    Report Number
    1416980-2013-01549
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    October 12, 2012
    Report Date
    November 5, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS SERVICED BY A SERVICE TECHNICIAN. THIS IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE ROOT CAUSE OF THE F-73 ALARM WAS DETERMINED TO BE A SKEWED CN201 CONNECTOR. NO REPAIRS HAVE BEEN PERFORMED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT. CONCLUSION: WAS SELECTED BECAUSE THIS IS THE MOST APPLICABLE CODE TO THE PROBLEM. THE PROBLEM WAS CONFIRMED. HOWEVER, THE PROBLEM CANNOT CONCLUSIVELY BE ASSIGNED TO A HUMAN FACTORS ISSUE. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION IS IN PROGRESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A FLOGARD VOLUMETRIC INFUSION PUMP WAS FOUND TO HAVE FAILURE CODE F73 IN THE ALARM LOG. THIS WAS NOT REPORTED BY THE CUSTOMER. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30516 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1