Model note · Infusion Pump
B. Braun Infusomat Space Volumetric Infusion Pump
The Infusomat Space is a small linear peristaltic volumetric pump, about 1.4 kg, for adults, children and neonates, delivering fluids, drugs, blood and blood products by intravenous, intra-arterial, subcutaneous and epidural routes. Pumps stack into a SpaceStation, whose SpaceCom module links them to the hospital network over a CAN bus, and drug libraries come from the B. Braun Drug Library Manager. Its main US recall (2023, Class I) was a false upstream occlusion alarm that stops the pump, a serious risk when vasopressors are running.
The model
Maker, model and type.
- Maker
- B. Braun Medical Inc. (B. Braun Melsungen AG group)
- Model
- Infusomat Space Volumetric Infusion Pump (large volume pump, software 686G)
- 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 code FRN | Source |
| Clearances | K062700 (2006, original pump), K083689 (2009, barcode, outbound wireless and PCA), K142596 (18 June 2015, inbound drug library upload and EHR autoprogramming) | Source |
| Rate range | 0.1 to 1200 mL/h: steps of 0.01 mL/h up to 99.99, 0.1 mL/h from 100 to 999.9, 1 mL/h from 1000 to 1200 | Source |
| Accuracy | Set rate plus or minus 5% to IEC/EN 60601-2-24, held for at least 96 hours on one set; bolus typically plus or minus 5% above 1 mL; the pump shuts off if a fault causes a 1.4 mL wrong dose | Source |
| Occlusion | Downstream alarm in 9 levels from 225 to 900 mmHg; mechanical limit 1575 mmHg (210 kPa) under fault conditions; upstream alarm in 9 levels from -90 to -160 mmHg | Source |
| Time to occlusion alarm | At level 9 (900 mmHg): about 46:50 min at 1 mL/h, 2:06 min at 25 mL/h, 0:24 min at 100 mL/h, with up to 0.18 mL bolus held in the line | Source |
| Air detection | Upstream sensor sees bubbles of 0.01 mL; alarms on a single bubble of 0.02 to 0.3 mL or on 1.5 mL/h of accumulated air (both set in the service program) | Source |
| Power | NiMH battery, about 4 hours at 100 mL/h when new, about 6 hours to recharge; external adapter 100 to 240 V AC or SpaceStation | Source |
| Protection and size | Defibrillator proof, type CF; IP22; 214 x 68 x 124 mm; about 1.4 kg | Source |
| Drug library and logs | Up to 720 drug names with therapy data; history log of 1000 entries plus alarm and keystroke logs, read through the service program | Source |
Recalls
Known FDA recalls.
- Z-0123-2024 and Z-0124-20242023-09-21
Upstream occlusion alarm with no occlusion stops the pump (models 8713051U and 8713052U; 10,655 units in the US; 51 complaints, one injury, one death). Class I.
FDA record - Z-0355-20242023-11-01
Infusomat administration sets: tubing diameter or length out of tolerance causing false air in line alarms that stop the infusion.
FDA record - Z-0603-2026 and related2025-10-29
ADDitIV component in sets used with the Infusomat Space: backflow from the secondary (piggyback) container into the primary and failure to prime.
FDA record
Safety
Safety warnings from the record.
- A false occlusion alarm stops the infusion; for vasopressors and other high risk drugs FDA reported one death and one injury, and B. Braun advised keeping a second pump ready and using affected pumps only for low risk drugs until serviced. Source
- At high bolus rates such as 1200 mL/h, 0.33 mL is given every second; the IFU warns to watch the bolus volume to avoid overdose. Source
- Not safe as a stand alone device near MRI. Source
- Several lines with different rates joined at one patient port can change the rate of every infusion past the join. Source
Sources
Where this note comes from.
- B. Braun, Infusomat Space and Accessories Instructions for Use (US, software 686G)
- FDA 510(k) K142596 summary, Infusomat Space Volumetric Infusion Pump System
- FDA 510(k) K083689 summary (barcode, wireless, PCA)
- FDA recall notice, Infusomat Space Large Volume Pump, 2023
- openFDA device recall and MAUDE records
Not covered: The service manual is not public, so internal fault codes, calibration steps and part numbers are not included; the messages under error codes are the operator alarm messages from the IFU. Technical data are from the US IFU for software 686G; later software may differ. MAUDE counts include user and set issues and are trends only. The 1.4 mL single fault figure and time to alarm table are read from the IFU table layout and should be checked against the printed IFU.
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