Model note · Infusion Pump
CareFusion BD Alaris System
The BD Alaris System is a modular pump: one PC Unit (8015) carries the screen, power and network, and up to four modules clip onto its sides (large volume Pump Module 8100, Syringe 8110, PCA 8120, EtCO2), plus an Auto-ID barcode module as a fifth. Guardrails drug libraries set dose limits. After many recalls, BD gained a new 510(k), K211218, on 21 July 2023 for updated hardware and v12 software with stronger cybersecurity. Most failures in the recall record are mechanical: the pump module bezel, keypad fluid ingress and the inter unit connectors.
The model
Maker, model and type.
- Maker
- CareFusion 303, Inc. (BD)
- Model
- BD Alaris System with Guardrails Suite MX v12 (PC Unit 8015 with Pump Module 8100)
- Device type
- Infusion Pump
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| FDA classification | Infusion pump, 21 CFR 880.5725, Class II, product codes FRN (Pump), FRN syringe module, MEA (PCA) and CCK (EtCO2 analyser) | Source |
| Clearances | K091308 (2009, PC Unit 8000 and 8015), K133532 (2014, Guardrails Suite MX), K211218 (21 July 2023, v12.1.2), K243855 (25 April 2025) | Source |
| Module rules | Up to four infusion or monitoring modules per PC Unit, plus the Auto-ID Module as a fifth; only one PCA and one EtCO2 module; spread modules evenly on both sides for balance on the pole | Source |
| Rate range | Pump and PCA Modules 0.1 to 999 mL/h; Syringe Module 0.01 to 999 mL/h | Source |
| Pump Module accuracy (v12) | System flow accuracy -19% to +5.5% at 1 to 999 mL/h and -8% to +5.5% at 0.1 to 1 mL/h, tested to AAMI TIR101:2021 conditions (the older label said plus or minus 5%) | Source |
| Maximum infusion pressure | Pump Module 525 mmHg; Syringe Module about 800 mmHg without the pressure sensing disc and 1060 mmHg with it | Source |
| Power | 100 to 240 V AC, 50/60 Hz, 150 VA maximum; rechargeable 12 V, 4000 mAh NiMH battery in the PC Unit | Source |
| Protection and environment | IPX2 (v12; the earlier system was IPX1); operating pressure 525 to 795 mmHg, so not for hyperbaric chambers; maximum supported configuration 13 kg | Source |
| Contraindication | Not for the enteral route (v12) | Source |
Recalls
Known FDA recalls.
- Z-1217-20262025-11-06
Pump Modules 8100 flashed with a daylight saving date and time that can break hospital network interoperability.
FDA record - Z-0430-20262025-10-17
Dropped or jarred Pump Modules can have a damaged bezel, causing over or under infusion, free flow or failure to calibrate.
FDA record - Z-2179-20252025-07-08
Pump Module 8100 may perform outside its flow, bolus and occlusion time to alarm ranges with compatible sets.
FDA record - Z-1231-20252025-01-23
User manual wrongly instructed leaving the safety clamp open when reloading a set.
FDA record - Z-3138-20242024-08-15
PC Units 8015 with bent female IUI connectors may not work, delaying infusion or monitoring.
FDA record - Z-1192-20232023-01-24
PC Units with certain software, network cards and IP addresses lose wireless connection and cannot receive new datasets.
FDA record - Z-2909-20202020-08-04
Keypad keys stuck or unresponsive after fluid ingress, delaying or interrupting infusion.
FDA record
Safety
Safety warnings from the record.
- An earlier user manual wrongly said to leave the safety clamp open when reloading a set; with the roller clamp also open this can cause accidental over infusion. Source
- In 2025 BD warned that Pump Modules used with compatible sets may perform outside their stated flow, bolus and occlusion alarm ranges. Source
- The PC Unit and modules cannot be started remotely; only infusion parameters can be sent from the EHR and a clinician confirms at the pump. Source
Sources
Where this note comes from.
- FDA 510(k) K211218 summary, BD Alaris System with Guardrails Suite MX v12.1.2
- FDA 510(k) K243855 summary, BD Alaris Infusion System with Guardrails Suite MX
- openFDA 510(k) records for the Alaris name
- openFDA device recall records, Alaris 8015 and 8100
Not covered: The Alaris technical service manual is not public, so calibration steps, part numbers and the full system error list are not included; the error codes above are only those named in FDA recall records. There are more than 30 recall events for the 8015 and 8100 since 2013; seven recent ones are listed. The K243855 summary (2025) was downloaded but its changes are not yet folded in.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Infusion Pump