PharmGuard 22-4075-0301-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517151107), received between May 13, 2021 and Apr 13, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (2 reports).

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.

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.

• MalfunctionApr 13, 2022Application Program Problem; Application Program Problem

  WHEN USING PHARMGUARD TOOLBOX TO TRANSFER OF DRUG LIBRARY FAILS, BUT IT CAN LEARN PUMP HISTORY SUCCESSFULLY. CREATED AND EMPTY LIBRARY TO RULE OUT ANY CONFLICTING PARAMETER COULD BE CAUSING THE TRANSFER TO FAIL, BUT IT STILL FAILED. UNINSTALLED AND REINSTALLED DRIVERS, STILL FAILED. AFTER RULING OUT SOFTWARE ISSUES I DETERMINED THAT IT MUST BE A HARDWARE ISSUE AND RECOMMENDED THEY ORDER A NEW IR DEVICE AND CABLE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14103813 ↗
• MalfunctionMay 14, 2021Computer Software Problem; Computer Software Problem

  INFORMATION RECEIVED A SMITHS MEDICAL SYRINGE INFUSION PUMPS/PHARMGUARD TOOLBOX SOFTWARE WAS NOT IN PUMP CORRECTLY. THE CUSTOMER ALSO DELETED A CATEGORY RESP/GI/LIVER FROM NICU 1-5KG IN ORDER TO ADD BLOOD PRODUCTS AND THE SAME THING HAPPENED UNDER THE SELECTED MODES. CUSTOMER DID NOT TOUCH OR REARRANGE THESE AT ALL. PHARMGUARD TOOLBOX 2 SOFTWARE. THIS IS RELATED TO THE LIBRARY SOFTWARE USED TO BUILD AND MAINTAIN THE DRUG LIBRARY ON THE PUMP. NO PATIENT OR PUMP WAS INVOLVED. SMITHS FROM PHARMACY HAS BEEN ABLE TO REPLICATE THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829442 ↗
• MalfunctionMay 13, 2021Computer Software Problem; Computer Software Problem

  INFORMATION RECEIVED A SMITHS MEDICAL SYRINGE INFUSION PUMPS/PHARMGUARD TOOLBOX SOFTWARE WAS NOT IN PUMP CORRECTLY. THE CUSTOMER ALSO DELETED A CATEGORY RESP/GI/LIVER FROM NICU 1-5KG IN ORDER TO ADD BLOOD PRODUCTS AND THE SAME THING HAPPENED UNDER THE SELECTED MODES. CUSTOMER DID NOT TOUCH OR REARRANGE THESE AT ALL. PHARMGUARD TOOLBOX 2 SOFTWARE. THIS IS RELATED TO THE LIBRARY SOFTWARE USED TO BUILD AND MAINTAIN THE DRUG LIBRARY ON THE PUMP. NO PATIENT OR PUMP WAS INVOLVED. SMITHS FROM PHARMACY HAS BEEN ABLE TO REPLICATE THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11823222 ↗

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-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-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-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

…and 1 more.