BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED AMBULATORY TUBING

    MDR report key: 6958053 · Received October 18, 2017

    Report

    Report Number
    6958053
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    September 19, 2017
    Report Date
    September 28, 2017
    Manufacturer
    WALKMED LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WALKMED INFUSION PUMP TUBING LEAKED AT CONNECTION SITE. MULTIPLE INCIDENTS. MULTIPLE INCIDENTS HAVE OCCURRED WITH PATIENTS IN A HOMECARE SETTING AND THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737780 WALKMED AMBULATORY TUBING PUMP, INFUSION FRN WALKMED LLC 20317530

    Patients

    Seq Age Sex Outcome Treatment
    1 NO OTHER THERAPIES