BEUDAMED
    FDA Enforcement Class II Terminated

    Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician; 5) Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.

    Recall: Z-1136-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-1136-2018
    Event ID
    78922
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 28, 2018
    Initiation Date
    November 13, 2017
    Classification Date
    March 19, 2018
    Termination Date
    September 16, 2025
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician; 5) Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.

    Reason

    Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the size of the syringe is unknown to the pump) results in an inability to complete pump programming. Misidentification of a syringe is where the pump misinterprets the syringe size.

    Code Info

    Product Codes 3010, 3010A with Model No. M03055, M02396, M02315, M02385, M02636, M02780, M02890, M03075, M03245, M03335, M03592, M03599, M03727, M03729, M03817, M03887, M04406, M04568, M04778, M04870, M05494, M05587, M05762, M05766, M05767, M05768, M05849, M06244, M07153, M07159, M07335, M07361, M07443, M07460, M08153, M08157, M08168, M08735, M08736, M08820, M08853, M08871, M08878, M09038, M09057, M09992, M10227, M10229, M10263, M10270, M10325, M10342, M10347, M10353, M10366, M10589, M10879, M10890, M10896, M10900, M11875, M11877, M11898, M11900, M11918, M11919

    Distribution

    Worldwide distribution- US nationwide Distribution and to the countries of : Australia, Barbados, Canada, Hong Kong, Indonesia, Jamaica, New Zealand, Philippines, Saudi Arabia, Singapore, South Africa, Trinidad and Tobago, United Arab Emirates, and United Kingdom.

    Quantity

    16,600 pumps total