The Imed Orion Infusion Pump and Administration Sets

• • Ongoing Z-0026-2018 FDA Class II ·initiated 9 Aug 2017

  The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.

• • Terminated Z-2700-2017 FDA Class II ·initiated 12 Jun 2017

  There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100.

• • Terminated Z-0950-2017 FDA Class I ·initiated 2 Dec 2016

  During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.

• • Terminated Z-1567-2014 FDA Class I ·initiated 23 Apr 2014

  CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used.

• • Terminated Z-2185-2012 FDA Class I ·initiated 29 Jun 2012

  The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received reports of customers experiencing motor stalls during infusion with Alaris Pump Module (model 8100) manufactured between August 2010 and July 2011.

• • Terminated Z-2205-2012 FDA Class I ·initiated 15 Jun 2012

  The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly

• • Terminated Z-1793-2009 FDA Unclassified (pre-2012) ·initiated 12 Jun 2009

  There is a potential risk of over infusion when certain fluids solidify in the pumping mechanism of the Alaris Pump module. This notification is to reinforce the importance of proper techniques for IV set loading and cleaning. When IV sets are improperly loaded, the set can tear and cause medication to leak and potentially enter the bezel area. Improper cleaning of the device, such as using hig

• • Terminated Z-1794-2009 FDA Unclassified (pre-2012) ·initiated 12 Jun 2009

  There is a potential risk of IUI connector failure in the Alaris System when these connectors become corroded or contaminated, which may result in an interruption of infusion with an audible and visual alarm. IUI connectors can become corroded or contaminated when exposed to fluid spills or improper cleaning. This notification is to reinforce the importance of inspection of IUI connectors prior

• • Terminated Z-1712-2008 FDA Unclassified (pre-2012) ·initiated 5 Mar 2008

  A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failure of the U9 Socketed Integrated Circuits (U9 IC) on the display board of the Alaris Syringe Module ("Syringe module") and Alaris PCA module ("PCA module") for modules manufactured on or before October 4, 2005. The user will be required to re

• • Terminated Z-1710-2008 FDA Unclassified (pre-2012) ·initiated 5 Mar 2008

  A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failures of the U19 Socketed Integrated Circuits (U19 IC) on the logic board of the Alaris Pump module ("Pump module"). The user will be required to replace the affected module.

• • Terminated Z-1711-2008 FDA Unclassified (pre-2012) ·initiated 5 Mar 2008

  A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors with the Alaris System due to the Inter-Unit Interface (IUI) connectors on all Alaris System modules (manufactured on or before March 26, 2004). Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March

• • Terminated Z-0568-05 FDA Unclassified (pre-2012) ·initiated 10 Nov 2004

  The device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module. To date there have been complaints from three (3) different customer locations.

510(k) Number

K950419 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• Macrodot Add-I-Med Admin. Set

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  FDA 510(k) K823347 Active Cleared 24 Nov 1982

• Imed Gemini 12 Nonvented Y-Type Blood/Solution Adm

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• Imed(R) Gemini(Tm) Pc-1 Volumetric Infusion Pump

  Class II

  FDA 510(k) K880479 Active Cleared 25 Apr 1988

• IV Filterset 5 Micrometer

  Class II

  FDA 510(k) K813445 Active Cleared 5 Jan 1982

• Imed Accuset Cassette

  Class II

  FDA 510(k) K812035 Active Cleared 28 Jul 1981

See all devices from Imed Corp. →