Medfusion 4000-0105-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,882 adverse event reports that list this exact device (DI 10610586043567), received between Aug 28, 2017 and Aug 28, 2026 — classified as 8 injuries, 2,874 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (1,174 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 2,882 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50503216 ↗
• MalfunctionAug 26, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461971 ↗
• MalfunctionAug 26, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461923 ↗
• MalfunctionAug 12, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226526 ↗
• MalfunctionJul 27, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50017237 ↗
• MalfunctionJul 27, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50013546 ↗
• MalfunctionJun 24, 2026Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE KEPT ALARMING AND DISPLAYED BLANK SCREEN. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25609158 ↗
• MalfunctionMay 21, 2026Failure to Infuse

  THE DEVICE WAS RETURNED BECAUSE IT WAS REPORTED THAT THE SYRINGE PLUNGER FAILED. THE REPORTED ISSUE WAS CONFIRMED DURING THE INVESTIGATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241350 ↗
• MalfunctionMay 15, 2026Device Sensing Problem

  UPON INVESTIGATION OF A MEDFUSION 4000 PUMP 'SYRINGE PLUNGER NOT IN PLACE ERROR' WAS FOUND IN THE EVENTS LOG HISTORY. THIS IS A HIGH PRIORITY ALARM WHICH WILL STOP ANY ONGOING INFUSION WHICH CONFIRMS THE INITIALLY REPORTED EVENT. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183835 ↗
• MalfunctionMay 1, 2026Crack; Unraveled Material; Failure to Infuse

  IT WAS REPORTED THAT THE PUMP HAD A FORCE SENSOR SYSTEM FAILURE DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057374 ↗
• MalfunctionApr 30, 2026Failure to Infuse

  IT WAS REPORTED THAT THE SYRINGE PLUNGER WAS NOT IN PLACE. CALIBRATION WAS PERFORMED; HOWEVER, THE ISSUE WAS NOT RESOLVED. THE EVENT DID NOT OCCUR DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044616 ↗
• MalfunctionApr 30, 2026Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE HAS MOTOR RATE ERROR. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044521 ↗
• MalfunctionApr 27, 2026Failure to Infuse

  IT WAS REPORTED THAT THE PUMP HAD CONSTANT MOTOR RATE ERROR. THE EVENT OCCURRED DURING PRE-TEST PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT,AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008503 ↗
• MalfunctionApr 22, 2026Unexpected Shutdown

  IT IS STATED THAT THE PUMP IS OFF AND TRIGGERS ALARMS SPONTANEOUSLY. IT IS UNABLE TO DIAGNOSE. AND THE SCREEN IS BLANK. THERE IS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24951656 ↗
• MalfunctionApr 21, 2026Electrical /Electronic Property Problem; Electrical Shorting

  IT WAS REPORTED THAT THE DAMAGE TO THE POWER BOARD AND SOME OF THE CONTACTS HAD GUNK ON THEM. THEY MAY HAVE SHORTED. THE EVENT OCCURRED DURING USE. THERE WAS NO PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945749 ↗
• MalfunctionApr 21, 2026Contamination; Electrical /Electronic Property Problem; Electrical Shorting

  IT WAS REPORTED THAT THE DEVICE HAD DAMAGE TO THE POWER BOARD, WITH VISIBLE RESIDUE ON SOME OF THE CONTACTS THAT MAY HAVE CAUSED A SHORT. THE EVENT OCCURRED DURING USE, BUT THERE WAS NO PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24944991 ↗
• MalfunctionApr 20, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT, DURING TESTING, THE DEVICE HAD MOTOR ISSUES. THERE WAS NO PATIENT INVOLVEMENT. EVALUATION OF THE RETURNED DEVICE IDENTIFIED A MOTOR RATE ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931787 ↗
• MalfunctionApr 15, 2026Defective Alarm

  IT WAS REPORTED THAT THE DEVICE DISPLAYED BATTERY TIME OUT ERROR AND BASE NOT RESPONDING. THE ISSUE HAPPENED DURING INFUSION AND THERE WERE A PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885130 ↗
• MalfunctionApr 15, 2026Mechanics Altered

  THE CUSTOMER RETURNED THE DEVICE STATING, ¿DURING TESTING THERE WAS A MOTOR ISSUE¿; DURING DEVICE EVALUATION THE COMPLAINT WAS CONFIRMED DUE TO TAMPERING TO MOTOR ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885089 ↗
• MalfunctionApr 8, 2026Failure to Infuse

  THE DEVICE WAS RETURNED AS IT WAS REPORTED THAT THE DEVICE WAS NOT CHARGING DURING TESTING THAT NEEDS INTERCONNECT BOARD. THE RESULTS OF THE INVESTIGATION FOUND THAT ISSUES OF MOTOR NOT RUNNING AND MOTOR RATE ERROR WERE IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818307 ↗
• MalfunctionApr 7, 2026Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE IS HAVING A MOTOR NOT RUNNING ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24806048 ↗
• MalfunctionApr 1, 2026Failure to Infuse

  IT WAS REPORTED THAT DURING ROUTINE PREVENTIVE MAINTENANCE INSPECTION THE DEVICE HAS SYRINGE FLANGE ERROR AND A BROKEN CABLE THAT IS SUPPOSED TO CONNECT TO THE MAIN BOARD. THERE WAS NO PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753054 ↗
• MalfunctionMar 30, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE PUMP WAS NOT RECOGNIZING THE SYRINGE SIZE, SYRINGE NOT IN PLACE ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727401 ↗
• MalfunctionMar 20, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE INFANT PATIENT RECEIVED INFUSION IN APPROXIMATELY 20 MINUTES, AND THE MEDICATION SHOULD HAVE BEEN ADMINISTERED OVER 1 HOUR. PER REPORTER, THE NURSE APPROPRIATELY PROGRAMMED THE PUMP, WHICH WAS CONFIRMED IN THE PUMP¿S DIAGNOSTICS. IN LESS THAN 20 MINUTES, THE PUMP STARTED ALARMING THAT THE SYRINGE INFUSING THE MEDICATION WAS NEAR EMPTY, AND WITHIN ABOUT 5 MINUTES THE SYRINGE WAS COMPLETELY EMPTY. ACCORDING TO THE PUMP, 05405 ML WAS DELIVERED, AND THERE WAS NO REMAINING VOLUME IN THE RESERVOIR. THE PROGRAMMED VOLUME TO BE INFUSED WAS 1.7250 ML, AND THE PROGRAMMED RATE WAS 1.73 ML PER HR. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650640 ↗
• MalfunctionMar 16, 2026Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE HAD MOTOR AND CLUTCH ERRORS DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604809 ↗

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