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Recall Observatory FDA recall evidence

Device product

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.

Z-1136-2018

November 13, 2017

Class II

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 78922
Status
Terminated
Classification
Class II
Quantity
16,600 pumps total
Official record key
device-enforcement:Z-1136-2018

Official wording

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 information: 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 pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.