Smiths Medical Medfusion 4000
Smiths Medical · Model Medfusion 4000
Safe & Reliable Medication Delivery High Accuracy Infusion: Delivers medication within ±2% accuracy Wide Flow Rate Range: From 0.01 mL/hr to 1130 mL/hr FlowSentry™ Pressure Monitoring: Enables early detection of occlusions for faster intervention Always-On Safety Mode: Promotes adherence to medication safety protocols from startup Smart Pump Technology PharmGuard® Medication Safety Software: Reduces programming errors with drug libraries Custom Drug Protocols: Configure care area-specific profiles and dosing limits Hard & Soft Limits: Prevent adverse drug events through intelligent safeguards Trend & Reporting Tools: Identify risks and improve clinical outcomes Wireless Connectivity & Integration Wireless Communication: Connects to PharmGuard® Server for remote updates Fast Drug Library Updates: No need for manual pump handling Robust Reporting Capabilities: Supports continuous quality improvement (CQI) initiatives Ease of Use & Efficiency Quick Library Feature: Start infusions in just three button presses Automatic Syringe Detection: Compatible with 1 mL to 60 mL syringe sizes Ergonomic Horizontal Design: Allows single-handed syringe loading User-Friendly Interface: Intuitive system reduces training time (Generated by AI)
Key tips
- ·Free-flow protection must be verified on every PM - a failed anti-free-flow clamp is a direct overdose risk.
- ·Test occlusion alarms in both directions - failing to alarm when it should is more dangerous than a false alarm.
- ·Battery run-time complaints are the most common real-world nuisance call - a full charge/discharge cycle test catches most of them.
Typical Failure Modes
Failure patterns typical of this equipment class - general BMET reference, not verified against this exact unit's own service history unless flagged. Severity is a category-level estimate.
Air-in-line detection
MediumSymptoms: Air-in-line alarm, infusion paused.
Root cause: Air in set, improperly primed tubing.
Free-flow (failure of anti-free-flow)
HighSymptoms: Uncontrolled flow when door open.
Root cause: Worn roller or failed free-flow valve.
Motor / drive failure
MediumSymptoms: Stalled infusion, inaccurate rate.
Root cause: Peristaltic motor or encoder wear.
Door / carriage sensor fault
LowSymptoms: Set not recognized, door-open error.
Root cause: Dirty or failed door microswitch.
Serviceable Parts & Consumables
The parts a BMET typically services on this class of equipment. Service class and relative cost are general engineering estimates for the category, not figures from this unit's documentation. Part numbers appear only when pulled from this unit's own service manual. Always confirm intervals and pricing against the manufacturer.
Occlusion sensor assembly
Class Periodic replacementRel. cost $$R&R Moderate
IV administration set
Consumable; per patient.
Class ConsumableRel. cost $R&R Easy
Peristaltic roller / pump mechanism
Common R&R on high-mileage pumps.
Class Periodic replacementRel. cost $$$R&R Difficult
Air detector / ultrasonic sensor
Class Periodic replacementRel. cost $$R&R Moderate
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Occlusion sensor assembly | Periodic replacement | $$ | Moderate |
| IV administration set Consumable; per patient. | Consumable | $ | Easy |
| Peristaltic roller / pump mechanism Common R&R on high-mileage pumps. | Periodic replacement | $$$ | Difficult |
| Air detector / ultrasonic sensor | Periodic replacement | $$ | Moderate |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Occlusion pressure and flow-rate accuracy verification
- ·Battery conditioning cycle
- ·Door latch and air-in-line sensor inspection
- ·Post-drop functional check before return to service
- ·Annual PM per manufacturer schedule
Troubleshooting Approach
A structured starting point derived from the failure modes above. Follow the manufacturer's service documentation for the actual procedure.
Symptom: Occlusion / downstream blockage
- Confirm the presentation - typically occlusion alarm, no flow, upstream pressure high - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: kinked set, clamped line, patient vein issue.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the iV administration set per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Symptom: Air-in-line detection
- Confirm the presentation - typically air-in-line alarm, infusion paused - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: air in set, improperly primed tubing.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the peristaltic roller / pump mechanism per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Technical Specs
- Infusion Pump Type
- Ambulatory
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Patient care floors
- ICU
- OR
- Oncology / infusion centers
- Home health (portable pumps)
Documents & Manuals
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4. Interruption of Bolus or Loading Dose Delivery, 5. Pump Displays Incorrect Bolus/Loading Dose, 6. Loading/Bolus Dose Below the Minimum Recommended Rate, 7. Motor Rate Error, 8. Incorrect Recall Last Settings, 9. Corrupt Configuration, 10. Auto Lock, 11. Toolbox Configuration Loading Dose Time Values. Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software (v6.0.0) installed on your pumps.
- RECALL
Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 2. Re-administered Loading Dose (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 3. Incorrect Critical Data Failure Alarm, 4. Interruption of Bolus or Loading Dose Delivery (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 5. Incorrect Total Bolus/Loading Dose Displayed (v1.1.0, v1.1.1, v1.1.2), 6. Volume Limit Before Bolus/Loading Dose Complete (v1.1.2), 7. Drug Library Lower Limit Displayed Incorrectly (v1.6.0, v1.6.1), 8. Depleted Battery Alarm (All versions previous to v1.6.5), 9. Loss of Wireless Connectivity (v1.5.0, v1.5.1, v1.6.0, v1.6.1, v1.6.4), 10. PharmGuard Server Password (v2.3, v2.4, v2.5). Smiths Medical corrected all issues included in this notification in previous software updates and the correct
- RECALL
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
- RECALL
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are no
- RECALL
Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation
- RECALL
Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001
- RECALL
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
- RECALL
There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy.
- RECALL
Customers who utilize PharmGuard Server Software (PGS) with Medfusion 4000 pumps manufactured prior to November 10, 2017, may experience wireless network connectivity issues on certain pumps due to a potential Radio Module issue on some Medfusion 4000 pumps.
- RECALL
Product has a lack of sterility assurance
- RECALL
Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.
- RECALL
Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the size of the syringe is unknown to the pump) results in an inability to complete pump programming. Misidentification of a syringe is where the pump misinterprets the syringe size.
- RECALL
Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the "Invalid Syringe Size" alarm.
- RECALL
There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the self-test. This recall occurred in 2015.
- RECALL
Smiths Medical is conducting a recall involving all Medfusion 4000 Syringe Infusion Pumps. Smiths Medical has identified an issue with electrical shorting at the AC power receptacle. Shorting can occur when saline solution or other conductive fluids (e.g., potassium chloride) enter the AC power receptacle. When this happens, sparking and/ or flames, accompanied by smoke, may appear at the AC po
- RECALL
Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm. When the device exhibits this failure mode, visual and audible alarms will sound and the device ceases operation.
- RECALL
Pumps rendered inoperable at power up (displaying a blank screen and alarm).
- RECALL
Smiths Medical is conducting a correction of Medfusion Syringe Infusion Pumps, Models 3010 and 3010a, with obsolete software versions 2.0.2, 2.0.3, and 2.0.4. Smiths Medical has found that pumps with obsolete software may continue to run past the set volume limit. This can result in an over-delivery if the syringe is over-filled. Smiths Medical has received no reports of serious patient in
- RECALL
An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions.
- RECALL
Smiths Medical has become aware of an increased trend in reports of Motor Not Running (MNR) and Motor Rate Error (MRE) alarm message events with certain Medfusion Syringe Infusion Pumps, Models 3010A and 3500 (Pump). MNR/ MRE are high priority alarm messages which can occur for a variety of reasons as part of the usual self-test functionality of the Pump. The Pump is designed so that when its so
- RECALL
Delay in therapy. Keypad issues with Medfusion Syringe Infusion Pump, model numbers 3500-306 and 3500-415 ("Pump") have occurred during implementation or shortly after first being placed into use. These issues can be intermittent, and may render the Pump inoperable or the Pump may not respond to certain keypad button presses.
- RECALL
Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump's startup sequence when the pump's Preventative Maintenance Alarm goes off, preventing the pump from completing its power up routine. Lock-up occurs and the pump will not function.
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