Model note · Infusion Pump
BD Alaris Pump Module 8100
The Alaris Pump Module 8100 is the large volume infusion channel of the modular BD Alaris System. It clips onto an Alaris PC Unit, which provides the interface, power and Guardrails dose error reduction library, and is used across adult, paediatric and neonatal wards. Up to four modules can run independent infusions from one PC Unit, and the module drives fluid by linear peristaltic action on the pumping segment of a dedicated set.
The model
Maker, model and type.
- Maker
- CareFusion 303, Inc. (BD)
- Model
- Alaris Pump Module 8100
- Device type
- Infusion Pump
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Programmable flow rate | 0.1 to 999 mL/h | Source |
| System flow rate accuracy (v12, AAMI TIR 101 test conditions) | -19% to +5.5% at 1 to 999 mL/h; -8% to +5.5% at 0.1 to 1 mL/h | Source |
| Flow rate accuracy (earlier K133532 statement) | Plus or minus 5% at 1 to 999 mL/h; plus or minus 5.5% at 0.1 to 1 mL/h | Source |
| Maximum pumping pressure | 525 mmHg | Source |
| Post occlusion bolus (v12, standard conditions) | 0.3 mL for all pressure settings | Source |
| Dimensions | 3.3 in W x 8.9 in H x 5.5 in D | Source |
| Power and battery (system, via PC Unit) | 100 to 240 VAC, 50/60 Hz, 150 VA maximum; rechargeable 12 V 4000 mAh NiMH pack | Source |
| Ingress protection | IPX2 for the v12 system (predicate was IPX1) | Source |
| Operating atmospheric pressure (v12) | 525 to 795 mmHg; hyperbaric use excluded | Source |
| Configuration | Up to four infusion modules on one PC Unit | Source |
| FDA clearance | K211218, BD Alaris System with Guardrails Suite MX v12.1.2, product code FRN, decided 21 July 2023 | Source |
Recalls
Known FDA recalls.
- Z-1217-20262025-11-06
Modules flashed with a daylight saving time timestamp may lose PC Unit connectivity to hospital networks.
FDA record - Z-0430-20262025-10-17
Drops or severe jarring can damage the bezel assembly, causing inaccurate or unregulated flow or calibration failure.
FDA record - Z-2179-20252025-07-08
Module with compatible sets may fall outside flow, bolus and occlusion alarm performance ranges.
FDA record - Z-1231-20252025-01-23
User manual wrongly instructed leaving the safety clamp open when reloading a set.
FDA record - Z-3142-20242024-08-15
Bent female IUI connectors may make modules inoperable and delay infusion.
FDA record - Z-1309-20212021-03-03
Keypad lifting and fluid ingress causing unresponsive or stuck keys and channel errors.
FDA record - Z-2736-20202020-06-30
Broken platen elements (hinge posts, membrane frame) affecting delivery accuracy.
FDA record - Z-2718-20202020-06-30
Cleaning agents damaging IUI connectors, causing CHANNEL DISCONNECTED and stopped infusions.
FDA record - Z-1360-20202020-02-04
Several software faults including Error 255-XX-XXX, missing low battery alarm and KVO issues.
FDA record - Z-1768-20192018-04-13
Bezels moulded from weakened FR-110 plastic may crack or lose posts.
FDA record
Safety
Safety warnings from the record.
- Bezel damage from a drop can cause unregulated flow or over infusion even when the pump looks intact, so dropped pumps must be inspected before reuse. Source
- An earlier user manual wrongly said to leave the safety clamp open when reloading a set; leaving the roller clamp open risks accidental over infusion. Source
- Some fluids can solidify in the pumping mechanism and cause over infusion, so correct set handling matters. Source
- Use only cleaning agents BD approves; others have damaged IUI connectors and membrane frames. Source
- The v12 system is not indicated for hyperbaric chambers. Source
Sources
Where this note comes from.
- BD Alaris Pump Module product page
- FDA 510(k) K211218 summary, BD Alaris System with Guardrails Suite MX v12.1.2
- openFDA recall search, Alaris 8100
- openFDA MAUDE problem counts, model 8100
Not covered: The Alaris technical service manual and full user manual are distributed through BD's customer portal and were not publicly reachable from an official source, so the module's own error code list, calibration steps and part numbers are not included; the only codes listed are those quoted in FDA recall records. MAUDE counts for this model are inflated by bulk summary reporting and are not a clean failure rate. There are over 30 recall records for model 8100; only the most relevant are listed.
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