MEDFUSION 4000-0107-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517154313), received between May 4, 2022 and Sep 29, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Audible Prompt/Feedback Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

15 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 16, 2026.

Recalls naming this device

1. Aug 16, 2023Open, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE ARE PARTS MOVING INSIDE THE UNIT. PATIENT INVOLVEMENT UNKNOWN.

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

  MAUDE report 17847079 ↗
• MalfunctionJul 7, 2022Inaudible or Unclear Audible Prompt/Feedback; Inaudible or Unclear Audible Prompt/Feedback

  IT WAS REPORTED THAT THE DEVICE'S SPEAKER IS MUFFLED OUT OF BOX. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14946734 ↗
• MalfunctionMay 4, 2022Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  IT WAS REPORTED THAT WHEN THE MEDFUSION 4000 WIRELESS PUMPS ARE IN CLINICAL MODE AND ARE IN USE IN THE DEPARTMENTS, THE PUMPS ALARM AFTER THE INFUSION DELIVERY IS COMPLETED. THE FIRST ALARM SHOWS THE MESSAGE -SYSTEM FAILURE: PRIMARY AUDIBLE ALARM POST-. IMMEDIATELY AFTER THAT, ANOTHER A SECOND ALARM SHOWS -SYSTEM FAILURE: ACU WATCHDOG FAILURE-. THIS PROBLEM DOES NOT OCCUR EVERY TIME THE PUMP IS USED, BUT HAS OCCURRED INTERMITTENTLY OVER THE PAST 3 YEARS (2019-2022). DEVICE WAS USED TO REPLICATE THE REPORTED ISSUE, HOWEVER CLINICAL ENGINEERING HAS FOUND THAT THE ALARM DOES NOT OCCUR IN MAINTENANCE MODE. AS AN EXAMPLE, FROM THE PHARMGUARD SERVER, IT WAS FOUND THAT FROM (B)(6), THE ACU WATCHDOG FAILURE ALARM HAD OCCURRED A TOTAL OF 58 TIMES FOR 11 PUMPS. CLINICAL ENGINEERING WAS UNABLE TO DUPLICATE PROBLEM WHEN SIMULATING CLINICAL MODE AS WELL. THE ROOT CAUSE IS STILL NOT IDENTIFIED. REPRESENTATIVE FROM SMITHS MEDICAL WAS CONTACTED. REPRESENTATIVE MENTIONED THAT THEY WERE AWARE OF THE PROBLEM AND THAT ONE POSSIBLE CAUSE COULD BE WATER SEEPING INTO THE SPEAKER BOX AT THE BOTTOM OF THE PUMP. HOWEVER, WHEN EXAMINED, ALL PUMPS WERE FOUND TO BE DRY WITH NO WATER SEEPAGE. MORE THAN 15 PUMPS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14280092 ↗

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-1543-2024 · Dec 19, 2023 · Open, Classified
  Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
• 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-0864-2024 · Dec 19, 2023 · Open, Classified
  smiths medical Medfusion Model 4000 syringe pump
• 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, v1
• 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