BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED TRITON POLE MOUNT INFUSION PUMP

    MDR report key: 3939191 · Received June 18, 2014

    Report

    Report Number
    1723533-2014-00001
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    March 24, 2014
    Report Date
    June 18, 2014
    Manufacturer
    WALKMED INFUSION LLC
    Product Code
    FRN
    PMA / PMN Number
    K070529
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, WALKMED INFUSION CONTACTED THE CUSTOMER AND VERIFIED THE FOLLOWING PROGRAMMED PARAMETERS: RATE: 400 ML/HR. TARGET VOLUME: 200 ML. VOLUME DELIVERED: 400 ML. INTENDED INFUSION PERIOD: 30 MINUTES. INFUSION PERIOD: 30 MINUTES. THE PUMP IN QUESTION WAS RETURNED TO WALKMED INFUSION FOR AN INVESTIGATION. DURING INVESTIGATION, THE PUMP WAS SUBJECTED TO TWO DELIVERY ACCURACY TESTS. THE FIRST DELIVERY ACCURACY TEST UTILIZED 100 ML/HR WITH A TARGET OF 40 ML. THE PUMP DELIVERED 41.3 ML WHICH IS A 3.25% OVER DELIVERY. THE MFR SPECIFICATION FOR DELIVER IS WITHIN 5%. THE REPORTED EVENT WAS NOT DUPLICATED AND THE PUMP'S DELIVERY ACCURACY WAS WITHIN THE MFR'S SPECIFICATION.

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT "THE PUMP IS DELIVERING MEDICATION TWICE AS FAST AS IT IS PROGRAMMED TO DO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356686 WALKMED TRITON POLE MOUNT INFUSION PUMP INFUSION PUMP FRN WALKMED INFUSION LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1