BEUDAMED
    FDA Adverse Event Other Summary report: N

    MILLEX FG

    MDR report key: 966930 · Received November 2, 2005

    Report

    Report Number
    1216103-2005-00001
    Event Type
    Other
    Date Received
    November 2, 2005
    Date of Event
    November 1, 2004
    Report Date
    November 1, 2005
    Manufacturer
    MILLIPORE
    Product Code
    FPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "SHE WAS UNABLE TO DRAW UP SALINE AS WELL. SHE WAS ABLE TO PUSH SALINE THROUGH THE FILTER. OKT3 SHOULD HAVE DRAWN UP TO 5 ML, BUT BY THE TIME IT WAS ATTEMPTED TO BE DRAWN UP SO MANY TIMES, THE AMOUNT WAS 3.5 ML AND HAD TO BE WASTED. PHARMACY DREW UP A NEW DOSE. TWO SAMPLE FILTERS WERE SAVED. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO." MILLIPORE WAS NOTIFIED OF THE EVENT IN 09/05. MILLIPORE ALSO REC'D TWO SAMPLE MILLEX FILTERS (LOT #R4EN26326) FROM THE USER FACILITY FOR ANALYSIS. AFTER REVIEW OF THE ADVERSE EVENT REPORT AND SAMPLE MILLEX FILTERS (LOT # R4EN26326), IT WAS NOTED THAT MILLEX-FG (CAT # SLFG025LS) IS A STERILE HYDROPHOBIC FILTER. MILLEX HYDROPHOBIC FILTERS WILL NOT PASS AQUEOUS (WATER) BASED SOLUTIONS, BUT WILL REPEL THEM. PRODUCT 'INSTRUCTIONS FOR USE' STATES THAT MILLEX-FG IS INTENDED FOR ULTRA-CLEANING OR STERILIZING SMALL VOLUMES OF NON-AQUEOUS SOLVENTS OR GASES. THE OTK3 (ANTI-REJECTION DRUG) WAS THEN REVIEWED BY MILLIPORE AND IOWA HEALTH. OTK3 WAS FOUND TO BE AN AQUEOUS (WATER) BASED SOLUTION. SINCE, MILLEX-FG IS HYDROPHOBIC AND OTK3 IS AN AQUEOUS SOLUTION, OTK3 WILL NOT PASS THROUGH THE MILLEX-FG FILTER (AND THEREFORE VERIFIES THE ADVERSE EVENT DESCRIPTION). IT WAS DETERMINED, THROUGH DISCUSSIONS WITH THE USER FACILITY; THE RN USED THE INCORRECT MILLEX FILTER DURING THE ADVERSE EVENT. OTK3 REQUIRED THE USE OF A MILLEX-GS, SINCE OTK3 IS AN AQUEOUS BASED SOLUTION. UNFORTUNATELY, A HYDROPHOBIC MILLEX-FG WAS UTILIZED INSTEAD, THUS RESULTING IN THE ADVERSE EVENT.

    Description of Event or Problem · 1

    REGISTERED NURSE ATTEMPTED TO DRAW OTK3 (ANTI-REJECTION DRUG) THROUGH APPROX 6 MILLEX FILTERS WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLEX FG STERILIZING SYRINGE FILTER FPB MILLIPORE MILLEX FG 0.2 R4EN26326

    Patients

    Seq Age Sex Outcome Treatment
    1 *