# K111386: Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported Syringes (PSS) - Pathway: 510(k) (Traditional) - Applicant: Smiths Medical MD, Inc. - Decided: Aug 29, 2011 after 103 days - Product code: FRN (Pump, Infusion) - Device class: 2 - Regulation: 21 CFR 880.5725 - Recalls of this device: 16 (6 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 3 generations back to K940147 (1994). 11 ancestors in all. 4 later devices descend from it; 2 cite it directly. 5 of 16 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K040899: Medex 3000 Series MR Syringe Infusion Pump, Medex, Inc. (2004) Summary page 1. - K042432: Pharmguard Toolbox, Model G6000782, Medex, Inc. (2005) Summary page 1. - K023264: Medley Syringe Pump Module System, Model 8110, Alaris Medical Systems, Inc. (2002) Summary page 1. - K030459: Medley System with Medication Management System (MMS), Alaris Medical Systems, Inc. (2003) Summary page 1. ## Most influential descendants - K211125: Novum IQ Syringe Pump (2022), 1 descendant of its own - K160482: t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater (2016), 1 descendant of its own - K242390: Novum IQ Syringe Pump (40800BAXUS) (2024), 0 descendants of its own - K162080: t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater (2016), 0 descendants of its own ## Recalls of this device - Dec 19, 2023 · Class I · Z-0864-2024: 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 - Dec 19, 2023 · Class II · Z-1541-2024: 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 - Dec 19, 2023 · Class II · Z-1543-2024: 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 - Aug 16, 2023 · Class II · Z-0079-2024: 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 - Oct 10, 2022 · Class II · Z-0272-2023: 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 - Apr 18, 2022 · Class I · Z-1271-2022: 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 Ov - Jun 26, 2020 · Class I · Z-2734-2020: Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs. - Jun 26, 2020 · Class I · Z-2735-2020: Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs. - Oct 28, 2019 · Class I · Z-0610-2020: 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. - Oct 15, 2018 · Class II · Z-2554-2019: 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 - Apr 13, 2018 · Class II · Z-2662-2018: 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 siz - Nov 13, 2017 · Class II · Z-1134-2018: 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 th - Aug 22, 2017 · Class II · Z-0313-2018: 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 Syring - Dec 3, 2015 · Class II · Z-0653-2022: 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 - Nov 22, 2013 · Class II · Z-0540-2014: 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 occu - Feb 14, 2012 · Class I · Z-2107-2012: 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 exhib ## Indications for use The PharmGuard® Supported Syringes is an accessory to the PharmGuard® Toolbox 2 Medication Safety Software that expands the available supported syringes that can be selected when creating user defined configuration parameters using the PharmGuard® Toolbox 2 Medication Safety Software. The Medfusion® Model 4000 Syringe Infusion Pump is indicated for the following uses: In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, Enteral solutions and other therapeutic fluids. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral, By the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus. In critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician. Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla. The PharmGuard® Toolbox 2 Medication Safety Software is indicated to provide a vehicle to create and securely upload user-defined configuration parameters a library of drug names and associated user-defined infusion parameters to Medfusion® Model 4000 Syringe Infusion Pump with software version V1.0 or higher. The PharmGuard® Toolbox 2 Medication Safety Software collects and downloads operational, infusion and alarm history events, library usage counts, and PharmGuard® safety events from the Medfusion® Pump. It is intended to provide a dataset users can collect and analyze to improve overall processes and lessen the likelihood of operator error when entering infusion parameters into the Medfusion® Pump. Source page: https://510kreport.com/device/K111386 Methodology: https://510kreport.com/methodology