Medfusion 3500-0600-82Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 10610586043017), received between Mar 2, 2020 and Nov 10, 2025 — classified as 89 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (31 reports).

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

16 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-1540-2024 · 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-0078-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PUMP EXHIBITED A CHECK BARREL CLAMP. DURING PHYSICAL INSPECTION, IT WAS FOUND THAT THERE WAS A PRIMARY AUDIBLE ALARM. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23514164 ↗
• MalfunctionMar 3, 2025Device Sensing Problem; Material Deformation; Device Sensing Problem; Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS NOT RECOGNIZING THE SYRINGE SIZE, AND THE DEVICE SEEMED TO NOT BE CALIBRATED CORRECTLY. THE UNIT WAS JUST IN FOR REPAIR FOR A WATCHDOG ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21510430 ↗
• MalfunctionOct 23, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE GOT WATCHDOG ERROR. NO PHYSICAL DAMAGE WAS REPORTED. THERE WAS NO PATIENT HARM, INVOLVEMENT OR DELAY OF THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516779 ↗
• MalfunctionJul 9, 2024False Alarm; Obstruction of Flow; False Alarm; Obstruction of Flow

  IT WAS REPORTED THAT THE DEVICE HAD A FORCED SENSOR OCCLUSION DETECTOR. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND UNKNOWN HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19701428 ↗
• MalfunctionOct 31, 2023Device Alarm System; Mechanical Problem; Device Alarm System; Mechanical Problem

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A CHECK SYRINGE PLUNGER SENSOR ERROR WHEN TURNED ON. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18042299 ↗
• MalfunctionAug 31, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THE DEVICE EXHIBITS INCORRECT SYRINGE SIZE IN THE DISPLAY DESPITE CORRECT INFORMATION BEING INPUT.

  Patient problems: Insufficient Information

  MAUDE report 17667007 ↗
• MalfunctionAug 8, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE SHOWED A "SYRINGE OUT OF PLACE" ERROR MESSAGE. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17484468 ↗
• MalfunctionJul 13, 2023Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE EXHIBITED THE FLANGE DOWN BUT PUMP NOT RECOGNIZING IT. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17320211 ↗
• MalfunctionApr 18, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED THE DEVICE HAS A SYSTEM FAILURE, PRIMARY AUDIBLE ALARM POST. NO REPORT OF PATIENT INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765346 ↗
• MalfunctionApr 18, 2023Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

  IT WAS REPORTED THE DEVICE WAS SHOWING MAINTENANCE BATTERY DEPLETED, WILL NOT STAY ON EVEN WHEN CONNECTED TO POWER SUPPLY. TRIED NEW POWER SUPPLY. NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765101 ↗
• MalfunctionMar 29, 2023Device Alarm System; Display or Visual Feedback Problem; Device Alarm System; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PUMP, WHEN TURNED ON THE SCREEN WOULD LIGHT UP BUT NOTHING ON THE DISPLAY, AND BEEPS LIKE THERE IS AN ERROR BUT CANNOT NOT SEE SCREEN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16636023 ↗
• MalfunctionMar 14, 2023Power Problem; Power Problem

  IT WAS REPORTED THAT THE PUMP WOULD NOT TURN ON AND SHOWS NO INDICATION OF BEING CHARGED. HAVE TRIED MULTIPLE POWER SUPPLIES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538763 ↗
• MalfunctionFeb 16, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PUMP WAS MARKED AS DEFECTIVE SINCE IT WAS UNABLE TO RUN ANYTHING THROUGH. NO PATIENT INJURY OR INVOLVEMENT WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16389433 ↗
• MalfunctionFeb 15, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PUMP WOULD NOT HOLD A CHARGE UNLESS PLUGGED IN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16380620 ↗
• MalfunctionOct 24, 2022Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT THERE WAS A FORCE SENSOR ERROR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657999 ↗
• MalfunctionOct 19, 2022Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE FLANGE ERROR OCCURRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15634081 ↗
• MalfunctionOct 19, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PLUNGER IS NOT WORKING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633795 ↗
• MalfunctionOct 19, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT SYRINGE CLIP IS NOT RETRACTING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633761 ↗
• MalfunctionOct 19, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PLUNGER IS NOT WORKING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633725 ↗
• MalfunctionOct 18, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE LEVER THAT HOLDS SYRINGE IN PLACE IS NOT WORKING NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15627176 ↗
• MalfunctionOct 18, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE PLUNGER WAS NOT WORKING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15627017 ↗
• MalfunctionOct 17, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE SYRINGE PLUNGER HOLDERS DO NOT OPEN WHEN THE RELEASE LEVER IS PRESSED. ALSO, THIS PUMP WILL NOT RECOGNIZE ANY SYRINGE SMALLER THAN A 12 CC. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15619794 ↗
• MalfunctionOct 14, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE WAS PRESENTING WITH AUXILIARY CONTROL UNIT WATCHDOG FAILURE AND PRIMARY AUDIBLE ALARM POST. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612011 ↗
• MalfunctionOct 14, 2022Defective Alarm; Failure of Device to Self-Test; Defective Alarm; Failure of Device to Self-Test

  IT WAS REPORTED THAT THERE WAS A SYSTEM FAILURE. FORCE PASSWORD TEST, BIOMED PASSCODE DID NOT WORK. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15608071 ↗
• MalfunctionOct 14, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE PUMP'S FLANGES THAT HOLD THE SYRINGE IN PLACE WERE UNABLE TO BE OPENED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606713 ↗

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-1541-2024 · Dec 19, 2023 · Open, Classified
  Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4
• Z-1543-2024 · Dec 19, 2023 · Open, Classified
  Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
• Z-0864-2024 · Dec 19, 2023 · Open, Classified
  smiths medical Medfusion Model 4000 syringe pump
• Z-0079-2024 · Aug 16, 2023 · Open, Classified
  Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 0105-51, h) 0105-78, i) 0105-249, j) 0106-00, k)
• 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-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-2735-2020 · Jun 26, 2020 · Open, Classified
  Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
• 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

…and 1 more.