BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED INFUSION TRITON FP INFUSION PUMP

    MDR report key: 4232340 · Received July 18, 2014

    Report

    Report Number
    1723533-2014-00002
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    WALKMED INFUSION
    Product Code
    FRN
    PMA / PMN Number
    K070529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INITIAL REPORTER, THE PATIENT WAS MONITORED BY LAB WORK AND THERE WERE NO ADVERSE EFFECTS. THE DEVICE IN QUESTION HAS NOT BEEN RETURNED TO WALKMED INFUSION. HOWEVER, THE RETURN OF THE DEVICE IS EXPECTED AND A FOLLOW UP REPORT WITH WALKMED INFUSION'S INVESTIGATION FINDINGS WILL BE FILED WITHIN 30 CALENDAR DAYS.

    Description of Event or Problem · 1

    THE WALKMED INFUSION TRITON FP PUMP WAS PROGRAMMED TO DELIVER 500 CC'S OF MEDICATION IN 24 HOURS. HOWEVER, THE PUMP DELIVERED 500 CC'S OF MEDICATION IN ABOUT 3 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423071 WALKMED INFUSION TRITON FP INFUSION PUMP INFUSION PUMP FRN WALKMED INFUSION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other