Medfusion 4000-0101-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,795 adverse event reports that list this exact device (DI 10610586040818), received between Mar 3, 2017 and Sep 29, 2026 — classified as 1 death, 3 injuries, 1,791 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (574 reports).

2 FDA recall records name this device's identifier, 2 still open.

14 other recalls cover devices cleared under the same FDA submission (K111386); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Dec 19, 2023Class IIOpen, Classified

   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.

   Z-1541-2024 · Root cause: Process control · Recall details · FDA record ↗

2. Aug 16, 2023Class IIOpen, Classified

   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.

   Z-0079-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,795 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933640 ↗
• MalfunctionSep 28, 2026Pumping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923744 ↗
• MalfunctionSep 25, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903126 ↗
• MalfunctionSep 22, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859861 ↗
• MalfunctionSep 21, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847382 ↗
• MalfunctionSep 18, 2026Pumping Problem

  It was reported that the pump displayed a Travel Coarse error, which is a high-priority alarm that could interrupt therapy if it recurs during use. The issue occurred during an occlusion test in which a stopcock was attached to the end of the syringe and the pump was allowed to run until the error was triggered. There was no patient involvement, and no patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819690 ↗
• MalfunctionAug 25, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50439161 ↗
• MalfunctionAug 11, 2026Circuit Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209603 ↗
• MalfunctionAug 10, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50194113 ↗
• MalfunctionAug 6, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50163741 ↗
• MalfunctionAug 4, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50135204 ↗
• MalfunctionJul 13, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25804472 ↗
• MalfunctionJul 13, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25803887 ↗
• MalfunctionJul 10, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25785209 ↗
• MalfunctionJun 26, 2026Failure to Infuse

  THE PUMP REPORTED A SYRINGE PLUNGER ERROR, WITH MULTIPLE OCCURRENCES OF THIS ISSUE NOTED. ADDITIONAL ERRORS AND CONCERNS WERE ALSO REPORTED ACROSS THE DEVICE FLEET. ALTHOUGH A PATIENT WAS INVOLVED, NO HARM OCCURRED. HOWEVER, THE ERROR RESULTED IN A DELAY IN THERAPY, AS THE NURSE HAD TO RELOAD THE SYRINGE OR POTENTIALLY OBTAIN A REPLACEMENT PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25638871 ↗
• MalfunctionJun 18, 2026Output Problem

  IT WAS REPORTED THAT DURING TESTING THE PUMP DISPLAYED ERRORS FORCE SENSOR BRIDGE TEST, POSITIVE SUPPLY BRIDGE EST, MOTOR DRIVE ERROR. THERE WAS NO PATIENT INVOLVEMENT AND PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552632 ↗
• MalfunctionJun 18, 2026Output Problem

  IT WAS REPORTED THAT DURING TESTING THE PUMP DISPLAYED ACU WATCHDOG FAILURE ERROR. THERE WAS NO PATIENT INVOLVEMENT AND PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552092 ↗
• MalfunctionJun 17, 2026Failure to Infuse; Device Sensing Problem

  IT WAS STATED THAT THE PUMP HAD AN ERROR OF SYSTEM FAILURE FORCE SENSOR TEST. THE HIGH-PRIORITY ERROR OCCURRED UPON POWER ON. THERE WERE NO PATIENT INVOLVEMENT AND NO PATIENT HARM. HOWEVER, IF THE ISSUE REOCCURS DURING INFUSION, IT WILL INTERRUPT THERAPY AND POTENTIALLY AFFECT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536051 ↗
• MalfunctionJun 16, 2026Use of Device Problem

  IT WAS REPORTED THAT A SYRINGE INFUSION PUMP DISPLAYED THE ERRORS DURING FORCE SENSOR BRIDGE TEST AND POSITIVE SUPPLY BRIDGE TEST. THE EVENT OCCURRED DURING PREVENTIVE MAINTENANCE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25519765 ↗
• MalfunctionJun 3, 2026Failure to Infuse

  IT WAS REPORTED THAT DURING THE PREVENTIVE MAINTENANCE (PM) OCCLUSION TEST, INSTEAD OF THE PLUNGER RETRACTING AS EXPECTED, AN AUDIBLE POP WAS HEARD AND THE PLUNGER STOPPED ABRUPTLY, DISPLAYING THE MESSAGE: ¿TRAVEL COURSE ERROR.¿ THE FAULT OCCURRED DURING THE OCCLUSION PHASE OF THE TEST AFTER THE GAUGE HAD FILLED WITH THE STOPCOCK CLOSED. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25383427 ↗
• MalfunctionJun 3, 2026Failure to Infuse

  IT WAS REPORTED THAT THE PUMP SHOWS MOTOR NOT RUNNING ERROR. IT WAS FOUND OUT DURING TURNING ON AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25376462 ↗
• MalfunctionJun 2, 2026Failure to Infuse

  DURING THE OCCLUSION TEST, IT WAS OBSERVED THAT INSTEAD OF THE PLUNGER RETRACTING DURING THE OCCLUSION PHASE, AN AUDIBLE ¿POP¿ WAS HEARD, AFTER WHICH THE PLUNGER STOPPED ABRUPTLY AND DISPLAYED A ¿TRAVEL COURSE ERROR¿ MESSAGE. THE ISSUE SPECIFICALLY OCCURRED AFTER THE GAUGE FILLED UP WITH THE STOPCOCK CLOSED. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25365706 ↗
• MalfunctionJun 2, 2026Failure to Infuse

  IT WAS REPORTED THAT DURING ROUTINE PREVENTIVE MAINTENANCE, THE PUMP EXHIBITED AN ISSUE DURING THE OCCLUSION TEST. INSTEAD OF THE PLUNGER RETRACTING AS EXPECTED, AN AUDIBLE POP WAS HEARD AND THE PLUNGER STOPPED ABRUPTLY, DISPLAYING A ¿TRAVEL COURSE ERROR¿ MESSAGE. THERE WERE NO PATIENT INVOLVEMENT AND NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364878 ↗
• MalfunctionJun 2, 2026Failure to Infuse

  DURING THE OCCLUSION TEST, IT WAS OBSERVED THAT INSTEAD OF THE PLUNGER RETRACTING DURING THE OCCLUSION PHASE, AN AUDIBLE ¿POP¿ WAS HEARD, AFTER WHICH THE PLUNGER STOPPED ABRUPTLY AND DISPLAYED A ¿TRAVEL COURSE ERROR¿ MESSAGE. THE ISSUE SPECIFICALLY OCCURRED AFTER THE GAUGE FILLED UP WITH THE STOPCOCK CLOSED. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364136 ↗
• MalfunctionJun 2, 2026Failure to Infuse

  DURING THE OCCLUSION TEST, IT WAS OBSERVED THAT INSTEAD OF THE PLUNGER RETRACTING DURING THE OCCLUSION PHASE, AN AUDIBLE ¿POP¿ WAS HEARD, AFTER WHICH THE PLUNGER STOPPED ABRUPTLY AND DISPLAYED A ¿TRAVEL COURSE ERROR¿ MESSAGE. THE ISSUE SPECIFICALLY OCCURRED AFTER THE GAUGE FILLED UP WITH THE STOPCOCK CLOSED. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363320 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111386. One submission often covers many models, so check the product and lot details in each record.

• Z-0864-2024 · Dec 19, 2023 · Open, Classified
  smiths medical Medfusion Model 4000 syringe pump
• Z-1543-2024 · Dec 19, 2023 · Open, Classified
  Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
• Z-0272-2023 · Oct 10, 2022 · Open, Classified
  Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environme
• Z-1271-2022 · Apr 18, 2022 · Open, Classified
  Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4
• Z-2735-2020 · Jun 26, 2020 · Open, Classified
  Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
• Z-2734-2020 · Jun 26, 2020 · Open, Classified
  Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
• Z-0610-2020 · Oct 28, 2019 · Terminated
  Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to me
• Z-2554-2019 · Oct 15, 2018 · Terminated
  Medfusion Model 4000 Syringe Infusion Pump, with PharmGuard Server Software (PGS). Sold under the following names: MEDFUSION 4000 Pump V1.0; MEDFUSION 4000 Pump V1.1, v1.1.1,
• Z-2662-2018 · Apr 13, 2018 · Terminated
  Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
• Z-1134-2018 · Nov 13, 2017 · Terminated
  Medfusion Syringe Pump 4000 Series The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion r
• Z-0313-2018 · Aug 22, 2017 · Terminated
  Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the
• Z-0653-2022 · Dec 3, 2015 · Open, Classified
  Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced usi
• Z-0540-2014 · Nov 22, 2013 · Terminated
  Medfusion 4000 Syringe Infusion Pumps Medfusion 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infu
• Z-2107-2012 · Feb 14, 2012 · Terminated
  Smiths Medical, Medfusion Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78