# K950419: The Imed Orion Infusion Pump and Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: Imed Corp.
- Decided: Jun 21, 1995 after 141 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 12 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
29 later devices descend from it; 5 cite it directly.
10 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) IMED Gemini PC-2TX Infusion Pump and Administration Sets: named in the summary without a submission number

## Most influential descendants
- K023189: Vista Basic with FM System (2003), 16 descendants of its own
- K062700: Infusomat Space Volumetric Infusion Pump System (2006), 15 descendants of its own
- K140838: IV Administration Set with Hand Pump (2014), 6 descendants of its own
- K051641: Alaris System PC Unit, Model 8001 (2005), 6 descendants of its own
- K091308: Alaris PC Unit, Models 8000 and 8015 (2009), 5 descendants of its own

## Recalls of this device
- Aug 9, 2017 · Class II · Z-0026-2018: The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.
- Jun 12, 2017 · Class II · Z-2700-2017: 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.
- Dec 2, 2016 · Class I · Z-0950-2017: During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.
- Apr 23, 2014 · Class I · Z-1567-2014: 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 "Del
- Jun 29, 2012 · Class I · Z-2185-2012: 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
- Jun 15, 2012 · Class I · Z-2205-2012: 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
- Jun 12, 2009 · Not classified · Z-1794-2009: 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 visua
- Jun 12, 2009 · Not classified · Z-1793-2009: 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
- Mar 5, 2008 · Not classified · Z-1712-2008: 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 
- Mar 5, 2008 · Not classified · Z-1710-2008: 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 Circuit
- Mar 5, 2008 · Not classified · Z-1711-2008: 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
- Nov 10, 2004 · Not classified · Z-0568-05: 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 sys

## Indications for use
The Orion™ Infusion System is intended for use in a health care facility t0 pump standard 1V fluids, medications, whole blood and packed red blood cells into a patientin a controlled manner. The system is electrically powered, with back up battery power available, and uses linear peristaltic pumping action to infuse fluids. The Orion System is capable of detecting air-in-line and occlusions. The Orion System is also indicated for Epidural infusions. Appropriate warnings and precautions 10 safely and accurately infuse Epidural are provided in the product labeling.

Source page: https://510kreport.com/device/K950419
Methodology: https://510kreport.com/methodology