BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED INFUSION IV ADMINISTRATION SET W/NEEDLEFREE Y-SITE & 0.22 MICRON FILTER

    MDR report key: 5697216 · Received June 3, 2016

    Report

    Report Number
    1723533-2016-00155
    Event Type
    Malfunction
    Date Received
    June 3, 2016
    Report Date
    May 9, 2016
    Manufacturer
    WALKMED INFUSION, LLC.
    Product Code
    FPA
    PMA / PMN Number
    K073444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION FOR THE DEVICE IN QUESTION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED WITHIN 30 CALENDAR DAYS TO DISCLOSE ANY FINDINGS FROM THE PRODUCT'S EVALUATION.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL PRODUCT EVALUATION INFORMATION HAS BEEN PROVIDED BY THE CONTRACT MANUFACTURER OF THIS PRODUCT. ON JUNE 14, 2016 WALKMED INFUSION INITIATED A VOLUNTARY MEDICAL DEVICE RECALL FOR THE TRITON AND TRITON FP INFUSION PUMPS (MODEL NUMBERS 300000 AND 400000). AS A RESULT OF THESE PRODUCTS BEING REMOVED FROM THE MARKET, ADDITIONAL INVESTIGATION WAS TERMINATED. THE INFORMATION CONTAINED HEREIN IS BEING PROVIDED TO THE FDA OR OTHER AUTHORITIES TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING.

    Additional Manufacturer Narrative · 1

    WHEN THIS REPORT WAS ORIGINALLY SUBMITTED, WALKMED INFUSION ASSIGNED AN INCORRECT DEVICE PRODUCT CODE. CODE "FPB" WAS INCORRECTLY ASSIGNED, WHEN "FPA" WAS THE CORRECT CODE.

    Description of Event or Problem · 1

    WHILE PRIMING THE ADMINISTRATION SET WITH SALINE, THE FILTER COMPLETELY DETACHED FROM THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353853 WALKMED INFUSION IV ADMINISTRATION SET W/NEEDLEFREE Y-SITE & 0.22 MICRON FILTER INTRAVASCULAR ADMINISTRATION SET WITH FILTER FPA WALKMED INFUSION, LLC. 1506092D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other