# K012383: Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii), Medsystem Patient C

- Pathway: 510(k) (Traditional)
- Applicant: Alaris Medical Systems, Inc.
- Decided: Oct 2, 2001 after 67 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 12 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002211 (2000). 2 ancestors in all.
13 later devices descend from it; 4 cite it directly.
4 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010924: Modification to Plum XL Infusion Pump, Abbott Laboratories (2001) Summary page 2.
- K002211: Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric Infusion Pump 2M8151, Baxter Healthcare Corp (2000) Summary page 2.

## Most influential descendants
- K050301: Mridium 3850 Mri Pump System (2005), 4 descendants of its own
- K133532: Alaris System with Guardrails Suite MX (2014), 3 descendants of its own
- K030136: Drip Alert (2003), 3 descendants of its own
- K090087: Mridium 3860 Mri Infusion Pump/Monitoring System (2009), 2 descendants of its own
- K211218: BD Alaris System with Guardrails Suite MX v12.1.2 (2023), 1 descendant of its own

## Recalls of this device
- Feb 4, 2020 · Class I · Z-1360-2020: 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 
- Feb 4, 2020 · Class I · Z-1362-2020: 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 
- Feb 4, 2020 · Class I · Z-1361-2020: 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 
- Jun 12, 2009 · Not classified · Z-1790-2009: There is a potential risk for medication not being delivered when IV tubing sets are occluded in the Alaris Pump module. This can occur if IV sets are set up in the infusion pumps but not used for an 
- Jun 12, 2009 · Not classified · Z-1791-2009: Affected Unit: Alaris PC Unit (Models 8000 and 8015) with software a versions 8 and above when used with the Alaris PCA module (Model 8120) There is a potential risk of over infusion related to a warn
- 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
- Mar 4, 2009 · Not classified · Z-1237-2009: The Alaris PCA module can potentially infuse above or below the intended infusion dose.
- 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
- Aug 10, 2006 · Not classified · Z-1484-06: This recall was initiated because of a potential for over infusion with all models of the Alaris SE Pumps (formerly the Signature Edition Infusion Pumps) caused by key bounce.
- 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
ALARIS Medical Systems infusion pumps are intended for use in today’s growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion pumps for the delivery of fluids, medications, blood and blood products. The following ALARIS Medical Systems infusion pumps are indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces: IMED® Gemini Infusion Pump / Controllers model PC-1® IMED® Gemini Infusion Pump / Controllers model PC-2® IMED® Gemini Infusion Pump/Controller model PC-2TX® IMED® Gemini Infusion Pump/Controller model PC-4* IVAC® Signature Edition® Infusion Pumps IVAC® MedSystem III®, Multi-channel Infusion Pumps IVAC® MedSystem I1I® Multi-channel Infusion Pumps with DLE ALARIS Medical Medley™ Patient Care System Note: See the appropriate Directions for Use (DFU) for infusion system specifications.

Source page: https://510kreport.com/device/K012383
Methodology: https://510kreport.com/methodology