BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVIDER PUMP SET 0.2 MICRON FILTER

    MDR report key: 394970 · Received May 15, 2002

    Report

    Report Number
    MW1025042
    Event Type
    Malfunction
    Date Received
    May 15, 2002
    Date of Event
    May 2, 2002
    Report Date
    May 3, 2002
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT RECEIVING NAFCILLIN 2 GM IV Q4HR VIA AIM PLUS PUMP THROUGH PKL FOR ARTERITIS. TWO EPISODES OF TUBING LEAKING AT THE FILTER SITE. THE FIRST EPISODE BROUGHT THE PT TO OUTPATIENT IV CLINIC WHEN THEY NOTICED LEAKING; THE SECOND EPISODE OCCURRED AS THEY WERE PRIMING NEW TUBING TO GET PT SET UP AGAIN. THE NURSE PRIMING THE TUBING REPORTED THAT FLUID WAS JUST GUSHING OUT AROUND THE FILTER - A VERY APPARENT LEAK. SO FAR THE PROBLEM HAS RESULTED IN HARDSHIP TO PT WHO IS FEELING VERY ILL AND IS WORRIED ABOUT THIS PROBLEM AND THE EXTRA TRAVELING TO CLINIC (60 MILES). LOT # REPORTED ONLY FOR TUBING THAT NURSE PRIMED. DID NOT HAVE PACKAGE FOR TUBING THAT PT REPORTED LEAKING. THIRD TUBING SET ALSO LEAKED THE FOLLOWING DAY (TWO THAT DAY). THIS IS ALSO BEING SENT TO ABBOTT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVIDER PUMP SET 0.2 MICRON FILTER PUMP TUBING FPA ABBOTT LABORATORIES * 79 045 4W

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other