# K133532: Alaris System with Guardrails Suite MX

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion 303, Inc.
- Decided: Aug 21, 2014 after 276 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 35 (28 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940147 (1994). 16 ancestors in all.
3 later devices descend from it; 2 cite it directly.
7 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051641: Alaris System PC Unit, Model 8001, Cardinal Health, Alaris Products (2005) Summary page 4.
- K091308: Alaris PC Unit, Models 8000 and 8015, Cardinal Health 303,Inc. (2009) Summary page 4.
- K950419: The Imed Orion Infusion Pump and Administration Sets, Imed Corp. (1995) Summary page 4.
- K012383: Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii), Medsystem Patient C, Alaris Medical Systems, Inc. (2001) Summary page 4.
- K023264: Medley Syringe Pump Module System, Model 8110, Alaris Medical Systems, Inc. (2002) Summary page 4.
- K072105: Alaris System with MMS, Model 8XXX, Cardinal Health 303,Inc. (2007) Summary page 4.
- K030459: Medley System with Medication Management System (MMS), Alaris Medical Systems, Inc. (2003) Summary page 4.

## Most influential descendants
- K211218: BD Alaris System with Guardrails Suite MX v12.1.2 (2023), 1 descendant of its own
- K243855: BD Alaris Infusion System with Guardrails Suite MX (2025), 0 descendants of its own
- K210074: Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable (2022), 0 descendants of its own

## Recalls of this device
- Feb 11, 2026 · Class II · Z-1645-2026: Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
- Sep 15, 2023 · Class I · Z-0185-2024: Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
- Sep 15, 2023 · Class I · Z-0184-2024: Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
- Sep 15, 2023 · Class I · Z-0186-2024: Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
- Mar 26, 2021 · Class I · Z-1544-2021: Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of o
- Mar 25, 2021 · Class I · Z-1651-2021: Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or
- Mar 24, 2021 · Class I · Z-1375-2021: Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, within infusion pump modules. Over time, the posts on the front bezel component may crack or 
- Mar 3, 2021 · Class I · Z-1309-2021: Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a differ
- Feb 26, 2021 · Class I · Z-1543-2021: Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of o
- Feb 25, 2021 · Class I · Z-2204-2021: Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of o
- Feb 25, 2021 · Class I · Z-1331-2021: Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of o
- Feb 25, 2021 · Class I · Z-1332-2021: Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of o
- Aug 4, 2020 · Class I · Z-2939-2020: Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infu
- Aug 4, 2020 · Class I · Z-2909-2020: The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to
- Aug 4, 2020 · Class I · Z-2910-2020: The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to
- Aug 4, 2020 · Class I · Z-2882-2020: The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion.
- Aug 4, 2020 · Class II · Z-2935-2020: Infusion pump component defect may result in interruption of patient monitoring
- Jun 30, 2020 · Class I · Z-2717-2020: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with 
- Jun 30, 2020 · Class I · Z-2716-2020: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with 
- Jun 30, 2020 · Class I · Z-2722-2020: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with 
- Jun 30, 2020 · Class I · Z-2736-2020: Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper 
- Jun 30, 2020 · Class I · Z-2741-2020: If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a power loss with a pro
- Jun 30, 2020 · Class I · Z-2740-2020: If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a power loss with a pro
- Jun 30, 2020 · Class I · Z-2721-2020: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with 
- Jun 30, 2020 · Class I · Z-2720-2020: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with 
- Jun 30, 2020 · Class I · Z-2718-2020: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with 
- Jun 30, 2020 · Class I · Z-2719-2020: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with 
- Jun 30, 2020 · Class I · Z-2723-2020: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with 
- Jun 30, 2020 · Class II · Z-2822-2020: LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
- Jun 30, 2020 · Class II · Z-2824-2020: LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
- Jun 30, 2020 · Class II · Z-2823-2020: LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
- Jun 30, 2020 · Class II · Z-2825-2020: LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
- Jun 30, 2020 · Class II · Z-2826-2020: LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
- Feb 4, 2020 · Class I · Z-1359-2020: 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 
- Apr 13, 2018 · Class I · Z-1768-2019: The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as 

## Indications for use
The Alaris System with Guardrails Suite MX is intended for use in professional healthcare facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products. The Alaris System with Guardrails Suite MX is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order. The Alaris System with Guardrails Suite MX is an interoperable system capable of communicating and exchanging data accurately, effectively, securely, and consistently with different information technology systems, sooftware applications, and networks, in various settings; and exchanging data such that the clinical or operational purpose and meaning of the data are preserved and unaltered.

Source page: https://510kreport.com/device/K133532
Methodology: https://510kreport.com/methodology