# K040899: Medex 3000 Series MR Syringe Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Medex, Inc.
- Decided: Apr 30, 2004 after 24 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 21 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 3 cite it directly.
4 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K053554: Compuflo (2006), 6 descendants of its own
- K101194: Navigator Delivery System (or Navigator DS) Model: Nav-010 (2011), 5 descendants of its own
- K112067: Navigator Delivery System (Navigator DS) (2011), 4 descendants of its own
- K111386: Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported Syringes (PSS) (2011), 4 descendants of its own
- K120830: Navigator Delivery System (Navigator DS) (2012), 3 descendants of its own

## Recalls of this device
- Dec 19, 2023 · Class I · Z-0863-2024: 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, 
- Dec 19, 2023 · Class II · Z-1540-2024: 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-1542-2024: 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-0078-2024: 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
- Aug 16, 2023 · Class II · Z-0076-2024: 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
- Aug 16, 2023 · Class II · Z-0077-2024: 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
- Apr 18, 2022 · Class I · Z-1272-2022: 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.
- 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-1136-2018: 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
- Nov 13, 2017 · Class II · Z-1135-2018: 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-0314-2018: 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 
- Jan 2, 2012 · Not classified · Z-1206-2012: Pumps rendered inoperable at power up (displaying a blank screen and alarm).
- Jun 22, 2010 · Not classified · Z-2121-2010: 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 
- May 14, 2010 · Class II · Z-0996-2013: 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.
- Nov 16, 2009 · Not classified · Z-0650-2010: 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 
- Nov 16, 2009 · Not classified · Z-0651-2010: 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 
- Dec 18, 2008 · Not classified · Z-1019-2009: 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. The
- Dec 18, 2008 · Not classified · Z-1018-2009: 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. The

## Indications for use
The Medex 3000 Series MRI Syringe Infusion Pump indications for use are as follows: · in the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids. * in the following delivery routes: arterial, epidural, intravenous, spinal, subcutaneous, and enteral. * in 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 or less. The syringe infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -100mm Hg as the high negative pressures can result in uncontrolled fluid flow.

Source page: https://510kreport.com/device/K040899
Methodology: https://510kreport.com/methodology