# K211218: BD Alaris System with Guardrails Suite MX v12.1.2

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion 303, Inc.
- Decided: Jul 21, 2023 after 819 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 16 (7 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K940147 (1994). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
7 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133532: Alaris System with Guardrails Suite MX, Carefusion 303, Inc. (2014) Summary page 7.

## Most influential descendants
- K243855: BD Alaris Infusion System with Guardrails Suite MX (2025), 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
- Nov 6, 2025 · Class II · Z-1217-2026: Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the
- Oct 17, 2025 · Class I · Z-0430-2026: If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so 
- Jul 8, 2025 · Class I · Z-2179-2025: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, a
- Feb 18, 2025 · Class I · Z-1304-2025: Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
- Feb 18, 2025 · Class I · Z-1305-2025: Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
- Jan 23, 2025 · Class II · Z-1231-2025: Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental ov
- Aug 15, 2024 · Class II · Z-3139-2024: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
- Aug 15, 2024 · Class II · Z-3138-2024: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
- Aug 15, 2024 · Class II · Z-3140-2024: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
- Aug 15, 2024 · Class II · Z-3141-2024: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
- Aug 15, 2024 · Class II · Z-3142-2024: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
- May 21, 2024 · Class II · Z-2262-2024: Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.
- 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.

## Indications for use
The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. See Pediatric*, Neonate**, and Adult Patient Population Tables for the module-specific variations. Administered fluids include pharmaceutical drugs, red blood cells, and other blood components (platelets and fresh frozen plasma) as required for patient therapy. The BD Alaris System is an interoperable system capable of communicating and exchanging data with compatible information technology systems. The BD Alaris System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, End-Tidal CO2 (EtCO2) Module, Auto-ID Module, Patient-Controlled Analgesia (PCA) Module, and associated software applications. The EtCO2 Module is a capnograph that continuously monitors end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). The BD Alaris Pump Module, Syringe Module, and the Alaris PCA Module are indicated for varying patient populations, routes of administration, and infusates.

Source page: https://510kreport.com/device/K211218
Methodology: https://510kreport.com/methodology