BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM

    MDR report key: 10127969 · Received June 8, 2020

    Report

    Report Number
    10127969
    Event Type
    Malfunction
    Date Received
    June 8, 2020
    Date of Event
    May 9, 2020
    Report Date
    May 19, 2020
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING TUBING AND PATIENT ASSESSMENT THE RN NOTED THE IV LINE WAS LEAKING AT THE IN-LINE 0.2 MICRON FILTER. THE INLINE FILTER IS LOCATED PROXIMAL TO THE IV LINE'S PUMP CASSETTE MECHANISM. THE LINE AND TPN SOLUTION WAS EXCHANGED OUT TO PREVENT POTENTIAL HAI TO PATIENT. IV SET AND MED SENT TO BIOMEDICAL FOR REPORTING AND LOGGING. THIS ISSUE OF LEAKING FILTERS IS AN ON-GOING ISSUE IN OUR NICU FOR OVER 18 MONTHS. OUR NICU HAVE REPORTED OVER 48 EVENTS OF LEAKING 0.2 PALL FILTERS ON THESE PRIMARY SETS OF VARIOUS LOT NUMBERS. THE MFG IS CURRENTLY TRYING TO DETERMINE THE ROOT CAUSE OF THESE FLUID LEAKS WHEN DISPENSING TPN BASED INFUSIONS. MANUFACTURER RESPONSE FOR PRIMARY IV SET WITH 0.2 MICRON FILTER, PRIMARY PLUM SET (PER SITE REPORTER). THE ISSUE OF LEAKING FILTER WHEN USED WITH TPN HAS BEEN A REPORTED ISSUE TWO YEARS AGO. ICU MEDICAL HAS YET TO DETERMINE OR RESOLVE ISSUE WITH CONSISTENT LEAKING TPN FILTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591716 PLUM SET, ADMINISTRATION, INTRAVASCULAR FPA HOSPIRA, INC. 1233605 4492961

    Patients

    Seq Age Sex Outcome Treatment
    1 47 DA