BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS EXTENSION SET

    MDR report key: 8248688 · Received January 15, 2019

    Report

    Report Number
    9616066-2019-00065
    Event Type
    Malfunction
    Date Received
    January 15, 2019
    Date of Event
    November 21, 2018
    Report Date
    December 21, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT OF A LEAK WAS CONFIRMED. HOWEVER, THE LEAK WAS FROM THE FILTER VENT, NOT FROM THE CONNECTION OF THE TUBING AND FILTER AS REPORTED. VISUAL INSPECTION SHOWED FLUID RESIDUE WITHIN THE FILTER. FUNCTIONAL TESTING RESULTED IN FLUID LEAKING OUT FROM THE VENT OF THE 1.2 MICRON FILTER. THE ROOT CAUSE OF THE LEAK WAS DETERMINED TO BE OVERSATURATION OF THE FILTER WHICH CAUSES THE INFUSATE TO LEAK/WEEP OUT THROUGH THE PATH OF LEAST RESISTANCE (THE FILTER AIR VENT).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT IN THE NICU/SCN (NEONATAL UNITS) DURING A LINE CHECK, LIPIDS WERE NOTED TO BE LEAKING FROM CONNECTION SITE OF THE MICROBORE TUBING AND LIPID FILTER. THERE WAS NO HARM.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT IN THE NICU/SCN (NEONATAL UNITS) DURING A LINE CHECK, LIPIDS WERE NOTED TO BE LEAKING FROM CONNECTION SITE OF THE MICROBORE TUBING AND LIPID FILTER. THERE WAS NO HARM.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT IN THE NICU/SCN (NEONATAL UNITS) DURING A LINE CHECK, LIPIDS WERE NOTED TO BE LEAKING FROM CONNECTION SITE OF THE MICROBORE TUBING AND LIPID FILTER. THERE WAS NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42999 ALARIS EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 20129E

    Patients

    Seq Age Sex Outcome Treatment
    1 20 DA 30914,30ML BD SYRINGE| PICC,EXT TUBING, THERAPY DATE (B)(6) 2018| PICC,EXT TUBING, THERAPY DATE (B)(6) 2018