BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3181829 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-16123
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 28, 2013
    Manufacturer
    SHARP CORPORATION OSAKA JAPAN
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS SERVICED BY A TECHNICIAN. THE DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE CAUSE COULD NOT BE IDENTIFIED. NO REPAIRS HAVE BEEN PERFORMED AT THIS TIME, AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. CONCLUSION CODE 19 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER THE EVALUATION IS NOT YET COMPLETE. ACCURACY TESTING DETERMINED THAT THE INFUSION RATES OF THE DEVICE WERE WITHIN SPECIFICATION. HOWEVER, VISUAL INSPECTION DETERMINED THAT THERE WAS A LARGE CRACK IN THE DOOR HINGE OF PUMP 1 WHICH COULD HAVE CONTRIBUTED TO ACCURACY ISSUES. UPON COMPLETION OF THE EVALUATION OR SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP UNDERINFUSED. THIS OCCURRED DURING PATIENT INFUSION WITH LEUKOTRIENE C (LTC). THE REPORTER STATED THAT THE PUMP "SAID LTC WAS 198, AND THERE WAS 650 LTC IN THE BAG". IT IS UNKNOWN WHETHER THERE WAS PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282278 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1 LEUKOTRIENE C