Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported Syringes (Pss)

• • Ongoing Z-0864-2024 FDA Class I ·initiated 19 Dec 2023

  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 corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software installed on your pumps.

• 2 recalls, same reason

  • Ongoing Z-1541-2024 FDA Class II ·initiated 19 Dec 2023
  • Ongoing Z-1543-2024 FDA Class II ·initiated 19 Dec 2023 ·on shared 510(k) K111386

  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.

• • Ongoing Z-0079-2024 FDA Class II ·initiated 16 Aug 2023

  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 notifying all customers of this potential issue.

• • Ongoing Z-0272-2023 FDA Class II ·initiated 10 Oct 2022

  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

• • Ongoing Z-1271-2022 FDA Class I ·initiated 18 Apr 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 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

• 2 recalls, same reason

  • Ongoing Z-2734-2020 FDA Class I ·initiated 26 Jun 2020
  • Ongoing Z-2735-2020 FDA Class I ·initiated 26 Jun 2020

  Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

• • Ongoing Z-0653-2022 FDA Class II ·initiated 3 Dec 2015

  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.

• • Terminated Z-0610-2020 FDA Class I ·initiated 28 Oct 2019

  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.

• • Terminated Z-2554-2019 FDA Class II ·initiated 15 Oct 2018 ·on shared 510(k) K111386

  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.

• • Terminated Z-2662-2018 FDA Class II ·initiated 13 Apr 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 size of a loaded syringe.

• • Terminated Z-1134-2018 FDA Class II ·initiated 13 Nov 2017

  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.

• • Terminated Z-0313-2018 FDA Class II ·initiated 22 Aug 2017

  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.

• • Terminated Z-0540-2014 FDA Class II ·initiated 22 Nov 2013

  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

• • Terminated Z-2107-2012 FDA Class I ·initiated 14 Feb 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 exhibits this failure mode, visual and audible alarms will sound and the device ceases operation.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K111386 ↗

FDA Product Code

FRN

Models / Variants

4000 Syringe Infusion Pump

Pharmguard Toolbox 2 Medication Safety Software

Supported Syringes (Pss)

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Smiths Medical MD, Inc. →