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What It Is
A braun infusion pump is an electromechanical device manufactured by B. Braun Medical Inc. to deliver medications, intravenous fluids, blood products, and nutrition into a patient’s vascular system in controlled volumes and rates. Regulated as a Class II medical device by the FDA under 21 CFR § 880.5725 (Product Code FRN), it replaces unmetered gravity flow with motor-driven accuracy.
The primary clinical role of an infusion pump b braun platform is administering continuous or intermittent infusions across acute, critical, surgical, and pediatric settings. Clinical users include acute care nurses, intensive care clinicians, anesthesiologists, hospital pharmacists, and biomedical engineering technicians. Medical facilities source institutional infusion pumps to standardize intravenous therapies across neonatal, pediatric, and adult populations.
How It Works or Is Built
A b braun infusion pump combines mechanical actuators, microprocessors, sensors, and dedicated tubing sets. The housing uses impact-resistant medical polymers encasing a backlit graphic LCD screen and alarm transducers.
B. Braun systems utilize two primary mechanical drive designs:
- Linear Peristaltic Drive (Large Volume Pumps): In volumetric units like the Infusomat® Space, a motorized camshaft presses fingers against silicone tubing, propelling fluid while sensors track pressure.
- Swivel-Drive Positive Displacement (Syringe Pumps): In syringe pumps like the Perfusor® Space, a motorized lead screw drives a pusher against the syringe plunger, delivering micro-volume infusions.
B. Braun’s platform uses the modular SpaceStation rack holding up to four pumps, stackable up to 16 pumps from one power cord. An integrated SpaceCom module manages communications via an internal CAN bus network. SpaceCom interfaces with hospital Ethernet or WLAN networks to connect with B. Braun’s Space OnlineSuite. Through Drug Library Manager software, pharmacists set Dose Error Reduction Systems (DERS) limits. Under FDA 510(k) K142596, the system supports EHR autoprogramming, though FDA rules prohibit remote start of infusions, requiring bedside clinician confirmation.
Operator input relies on B. Braun’s KeyGuard™ layout. Replacing numeric keypads with illuminated directional arrows, it requires clinicians to adjust values incrementally on screen, reducing transposition and decimal errors.
Types and Variants
B. Braun produces several infusion models tailored to specific fluid volumes, delivery rates, and care environments. The table below outlines cleared hardware models.
| Model / Platform | Pumping Mechanism | Typical Clinical Use | Key Difference & Clearance |
|---|---|---|---|
| Infusomat® Space | Linear peristaltic drive | Hydration, transfusions, piggybacks. | Volumetric large volume pump (0.1–1,200 mL/h); FDA 510(k) K142596; uses dedicated anti-free-flow silicone tubing sets. |
| Perfusor® Space | Lead-screw swivel drive | Vasopressors, pediatric micro-infusions. | Syringe pump (0.01–999.9 mL/h); FDA 510(k) K172831; cleared for acute care and medical air/ground transport. |
| Vista® Basic | Linear peristaltic drive | Med-surg units, outpatient infusion. | Standalone volumetric pump; FDA 510(k) K023189; straight-line set loading without multi-pump SpaceStation integration. |
| SpaceStation MRI | Shielded docking bay | Medication delivery during MRI scans. | MR Conditional shielded rack operating near 1.5T and 3.0T MRI systems. |
Sizes or Specifications That Matter
Technical specifications define flow rate precision, dosing limits, and physical dimensions. Values below trace directly to manufacturer documentation, FDA clearances, and IEC/EN 60601-2-24 standards.
| Specification Parameter | Infusomat® Space (LVP) | Perfusor® Space (Syringe) | Source / Standard |
|---|---|---|---|
| Delivery Flow Rate Range | 0.1 to 1,200 mL/h | 0.01 to 999.9 mL/h | B. Braun Technical IFU |
| Flow Rate Increments | 0.01 mL/h (0.1–99.99); 0.1 mL/h (100–999.9); 1.0 mL/h (1,000–1,200) | 0.01 mL/h steps across range | Manufacturer Instructions |
| Delivery Accuracy | ±5% | ±2% | IEC/EN 60601-2-24 Standard |
| Physical Dimensions (W × H × D) | 214 mm × 68 mm × 124 mm | 214 mm × 68 mm × 124 mm | B. Braun Datasheet |
| Device Weight (with battery) | Approx. 1.4 kg (3.1 lbs) | Approx. 1.4 kg (3.1 lbs) | Manufacturer Specs |
| Downstream Occlusion Pressure | 9 selectable levels (225 to 900 mmHg) | 9 selectable levels (up to 1.2 bar / 900 mmHg) | FDA 510(k) K142596 & K172831 |
| Cleared Administration Routes | Intravenous, intra-arterial, subcutaneous, epidural | Intravenous, intra-arterial, subcutaneous, epidural, enteral | FDA Indications for Use |
| FDA Regulatory Classification | Class II, 21 CFR § 880.5725, Product Code FRN | Class II, 21 CFR § 880.5725, Product Codes FRN, LZH | U.S. FDA CDRH Database |
| Biomedical Maintenance Cycle | Technical Safety Check (TSC) every 2 years | Technical Safety Check (TSC) every 2 years | B. Braun Service Manual |
How to Choose
Selecting an appropriate B. Braun infusion pump requires evaluating fluid volume, clinical precision, and mobility requirements:
- Fluid Volume and Precision: Large-volume hydration, blood transfusions, or parenteral nutrition require a volumetric pump like the Infusomat Space. Low-volume concentrated drugs (such as pediatric vasopressors) require the ±2% precision of the Perfusor Space syringe pump.
- Transport Requirements: For transfers or flights, the Perfusor Space is cleared under FDA K172831 for air and ground transport. Home care often uses ambulatory devices such as a Curlin ambulatory infusion pump.
- Syringe Compatibility: Perfusor Space units operate with standard clinical syringes, including hospital BD syringe inventory, provided the manufacturer barrel profile is selected in the pump calibration table.
- EHR Autoprogramming: Facilities requiring wireless order dispatch require SpaceStation docks equipped with SpaceCom modules compatible with DERS drug libraries.
Safe Use and Handling Basics
Safe operation of B. Braun infusion pumps follows manufacturer instructions, clinical protocols, and FDA device advisories:
- Use Dedicated Sets: Infusomat Space pumps require B. Braun administration sets with an Anti-Free-Flow Clamp (ASV) to prevent unmetered gravity flow.
- Purge Air and Manage Clamps: Prime lines fully before loading. Ensure manual clamps, such as an IV roller clamp, are open during active infusion and closed before tubing removal.
- Distinguish Mechanical Pumps from Gravity Sets: Unlike manual gravity IV tubing or unpowered microdrip tubing where flow relies on gravity, motor-driven pumps apply positive pressure, alarming upon downstream resistance.
- Prevent Secondary Backflow: Position secondary piggyback containers above the primary container and verify the primary line’s backcheck valve functions, addressing risks noted in FDA recalls Z-2392-2024 and Z-0617-2026.
- Adhere to Cleaning Protocols: Clean pump exteriors with approved disinfectants only, preventing liquid ingress into rear docking pins.
Common Mistakes
Technicians and clinical instructors frequently identify several avoidable operational errors:
- Misaligning the Anti-Free-Flow Clip: Failing to seat the safety clamp prevents door closure and can damage sensor pins.
- Selecting an Incorrect Syringe Brand: Confirming the wrong syringe model on a Perfusor Space distorts delivery because lead-screw advancement depends on barrel diameter calculations.
- Overriding Drug Library Limits: Bypassing DERS soft limits without pharmacy consultation increases medication error risks.
- Ignoring Upstream Occlusions: Neglecting closed roller clamps or unvented fluid bottles leads to pump stoppages and alarm fatigue.
- Overdue Biomedical Checks: Skipping the recommended two-year Technical Safety Check (TSC) allows sensor drift and battery wear to go undetected.
Frequently Asked Questions
What is the difference between an Infusomat Space and a Perfusor Space?
The Infusomat Space is a large volume peristaltic pump delivering IV bag fluids at 0.1 to 1,200 mL/h with ±5% accuracy. The Perfusor Space is a precision syringe pump driving disposable syringes (2 to 50/60 mL) at 0.01 to 999.9 mL/h with ±2% accuracy.
What does the KeyGuard keypad do on a B. Braun infusion pump?
The KeyGuard layout replaces a traditional 10-key numeric keypad with illuminated directional arrows. Clinicians adjust values incrementally while viewing the screen, preventing decimal slips and digit reversals.
Can a B. Braun infusion pump be started remotely via hospital EHR?
No. Under FDA 510(k) clearance K142596, Space pumps can wirelessly receive infusion parameters via EHR autoprogramming, but remote infusion initiation is prohibited. Bedside clinicians must verify line setup and start delivery manually.
How does the SpaceStation docking system communicate with hospital networks?
Stacked pumps link via multi-pin rear connectors inside the SpaceStation rack, creating an internal CAN bus network. An integrated SpaceCom module relays pump telemetry to hospital servers over Ethernet or WLAN.
Sources
- U.S. FDA Premarket Notification 510(k) K142596: Infusomat® Space Volumetric Infusion Pump System. Rockville, MD: CDRH; cleared June 18, 2015. Checked 2026-11-09. https://www.accessdata.fda.gov/cdrh_docs/pdf14/K142596.pdf
- U.S. FDA Premarket Notification 510(k) K172831: Perfusor® Space Syringe Infusion Pump System. Rockville, MD: CDRH; cleared June 12, 2018. Checked 2026-11-09. https://www.accessdata.fda.gov/cdrh_docs/pdf17/K172831.pdf
- U.S. Code of Federal Regulations. 21 CFR § 880.5725: General Hospital and Personal Use Therapeutic Devices—Infusion Pump. Legal Information Institute. Checked 2026-11-09. https://www.law.cornell.edu/cfr/text/21/880.5725
- U.S. FDA Medical Device Recalls: Class II Recall Z-2392-2024 & Z-0617-2026 (Infusomat Space Administration Sets). Rockville, MD: CDRH. Checked 2026-11-09. https://api.fda.gov/device/enforcement.json
- B. Braun Medical Inc. Infusomat® Space and Perfusor® Space Technical Instructions for Use & Service Manual (IEC/EN 60601-2-24). Bethlehem, PA. Checked 2026-11-09. https://www.bbraunusa.com
