BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED TRITON POLE MOUNT INFUSION PUMP

    MDR report key: 4881573 · Received July 1, 2015

    Report

    Report Number
    1723533-2015-00012
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Report Date
    January 16, 2015
    Manufacturer
    WALKMED INFUSION, LLC.
    Product Code
    FRN
    PMA / PMN Number
    K070529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS RETURNED TO WALKMED INFUSION AND INSPECTED BY WALKMED INFUSION PERSONNEL. THE DEVICE WAS SUBJECTED THROUGH A "FREE FLOW PROTECTION TEST", WHICH VERIFIES THE PUMP CAN PROPERLY OCCLUDE A TUBE SET WHEN THE DOOR IS IN A OPENED STATE. THE REPORTED EVENT WAS CONFIRMED AS THE DEVICE DID NOT PROPERLY OCCLUDE THE TUBING WHEN THE DOOR WAS IN AN OPENED STATE. A REVIEW OF THE MANUFACTURING AND SERVICE RECORDS DID NOT REVEAL ANY NONCONFORMITIES RELATED TO THE REPORTED EVENT. HOWEVER, WALKMED INFUSION'S RECORDS INDICATE THIS DEVICE WAS NEVER RETURNED TO WALKMED INFUSION FOR THE RECOMMENDED, ANNUAL PERIODIC MAINTENANCE.

    Description of Event or Problem · 1

    DURING SETUP, THE CLINICAL STAFF INSTALLED A TUBE SET INTO THE DEVICE IN QUESTION AND OBSERVED THE MEDICATION WAS "FREE FLOWING". AFTER THE PUMP WAS PROGRAMMED AT A RATE OF 10 ML/HR, THE CLINICAL STAFF CONTINUED TO OBSERVE "FREE FLOW".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428667 WALKMED TRITON POLE MOUNT INFUSION PUMP POLE MOUNT INFUSION PUMP FRN WALKMED INFUSION, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other