BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLEX GP FILTER UNIT 0.22 MICRON

    MDR report key: 4143194 · Received September 24, 2014

    Report

    Report Number
    4143194
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    February 27, 2014
    Report Date
    September 12, 2014
    Manufacturer
    EMD MILLIPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE MED SYRINGE FILTER UNIT WAS USED FOR AMIODARONE DRIP INFUSION.THE PATIENT HAD A CENTRAL LINE AND NEEDED ANTI-ARRHYTHMIC; AMIODARONE CONTINUOUS INFUSION. THE FILTER WAS CONNECTED TO A PRIMARY SMARTSITE INFUSION SET-IV TUBING. THE FILTER'S "OUTPUT SLIP LUER" FRACTURED IN THE CLAVE/VALVE OF THE IV TUBING SET. THE VALVE RETAINED THE FRACTURED OUTPUT SLIP LUER, ALLOWING FOR MEDICATION/BLOOD BACKFLOW. THE NURSE IMMEDIATELY CLAMPED THE PRIMARY IV LINE, ABOVE THE VALVE AND CHANGED THE IV SET FOR THE AMIODARONE DRIP TO A SMARTSITE LOW SORBING TUBING WITH A 0.2 MICRON FILTER. THE PATIENTS REMAINED STABLE. THE PATIENT'S BLOOD COUNT WAS CHECKED AFTER THE EVENT WHICH REMAINED WITHIN NORMAL LIMITS. NO ADVERSE AFFECTS. PER MFR'S RESPONSE TO THE HOSPITAL. MILLIPORE QUALITY MANAGEMENT STATED THAT THE DEVICE WAS NOT APPROVED FOR DIRECT PATIENT CARE USE AND THIS EVENT WAS WELL OUTSIDE OF THE RECOMMENDED USE OF FILTER. "SINCE THE PRODUCT WAS MISUSED THERE IS NO QA REQUIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593858 MILLEX GP FILTER UNIT 0.22 MICRON SET, ADMINISTRATION, INTRAVASCULAR FPA EMD MILLIPORE SLG033RS R3MA70320
    593859 SMARTSITE INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA EMD MILLIPORE 2420-0007 14026136

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR CARDIAC DRUGS