EASYPUMP 4540040-02Recalls & reported problems
B. Braun Medical Inc. · Easypump® ST 100-0.5-S1 · Class 2
Quick summary
This B. Braun Easypump elastomeric infusion pump has 41 adverse event reports naming its identifier, including 1 death and 1 injury. Reports mostly describe foreign particles in the fluid path, plus a few leaks, air bubbles, or over-infusion. There are no recalls for this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 41
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 04046964448942), received between Mar 22, 2019 and Mar 24, 2026 — classified as 1 death, 1 injury, 39 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (35 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem35
- Air/Gas in Device2
- Excess Flow or Over-Infusion2
- Adverse Event Without Identified Device or Use Problem1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- No Known Impact Or Consequence To Patient5
- Chemical Exposure1
- Death1
- Foreign Body Embolism1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2026Air/Gas in Device
AS REPORTED BY THE COMPLAINANT: TINY AIR BUBBLES IN PATIENTS PICC LINE AFTER MEROPENEM ADMINISTRATION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24675112 ↗MalfunctionFeb 11, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: 1 X FOREIGN PARTICLE FLOATING INSIDE THE MEMBRANE (FLUID PATH) - (12112025@4) - POST FILLING. 1 X FOREIGN PARTICLE FLOATING INSIDE THE TUBING (FLUID PATH) - (12112025@4) - POST FILLING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24317480 ↗MalfunctionOct 23, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, DURING DISINFECTION, PARTICLES WERE OBSERVED IN THE INFUSION LINE OF THE PUMP. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23366286 ↗MalfunctionJul 11, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: EASYPUMP LEAKED AT CONNECTION BETWEEN BOTTOM PORT AND TUBING. LEAK FOUND DURING COMPOUNDING. IS THERE CHEMO OR BLOOD EXPOSURE TO PRODUCT: (YES) FOR PHARMACY TECHNICIANS NO INJURY REPORTED.
Patient problems: Chemical Exposure
MAUDE report 17301958 ↗MalfunctionMay 9, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: 1 X BLACK PARTICLE IN THE CLOSING CONE IN THE PATIENT CONNECTOR (IN THE FLUID PATH) (09292022@1) - PRIOR TO FILLING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16898029 ↗InjuryApr 12, 2023Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: "THE FAMILY INITIATED THE EASYPUMP INFUSION AND THE PATIENT STOPPED BREATHING AND FACE COLOR CHANGED TO BLUE/PURPLE. THEY STOPPED THE PUMP AND THE PATIENT QUICKLY RECOVERED. THE FAMILY CALLED THEIR PEDIATRICIAN, AND THE PEDIATRICIAN ASSUMED THE PATIENT HAD CHOKED ON SOMETHING OR WAS VOMITING. THE FAMILY DID NOT WANT TO RESTART THE INFUSION, SO THEY CALLED EMS. EMS CAME AND RESTARTED THE EASYPUMP AND COMPLETED THE INFUSION WITH NO ISSUE. WHEN IT CAME TIME FOR THE NEXT INFUSION, THE PARENTS AGAIN DID NOT WANT TO START FOR FEAR OF THE EVENT OCCURRING AGAIN, SO THEY TOOK THE PATIENT TO THE ER. I'M UNCLEAR IF THE ER STARTED AN EASYPUMP THAT WE PREFILLED AND SENT TO THE PATIENT OR IF THEY USED ONE OF THEIR OWN, BUT THE NEXT DOSE WAS INITIATED IN THE ER. IT WAS THE ER DOCTOR THAT MENTIONED AIR EMBOLISM TO THE PARENTS.". "THE PATIENT HAD BEEN IN THE HOSPITAL AND ON THIS MEDICATION, CEFTRIAXONE, FOR A FEW DAYS AND HAD BEEN RECEIVING IT AT HOME VIA EASYPUMP FOR A FEW DOSES BEFORE THIS EVENT OCCURRED. THE INITIAL EASYPUMP INFUSION WAS GIVEN BY OUR VISITING NURSE WHO EDUCATED THE PARENTS ON HOW TO INITIATE THE REMAINING INFUSIONS. THIS EVENT WAS NOT THE FIRST
Patient problems: Foreign Body Embolism
MAUDE report 16724575 ↗MalfunctionOct 7, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT FOREIGN MATTER WAS OBSERVED IN THE FLUID PATH PAST THE FILTER OF THE DEVICE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15563469 ↗MalfunctionOct 4, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT FOREIGN MATTER WAS OBSERVED IN THE FLUID PATH PAST THE FILTER OF THE DEVICE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15538480 ↗MalfunctionFeb 25, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: BLACK PARTICLE IN THE CLOSING CONE IN THE PATIENT CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13599949 ↗MalfunctionFeb 14, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: SMALL BLACK PARTICLE IN THE PATIENT CONNECTOR (IN FLUID PATH).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13523914 ↗MalfunctionJan 26, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: BLACK PARTICLE IN THE PATIENT CONNECTOR UNDER THE CLOSING CONE (IN THE FLUID PATH).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13358738 ↗MalfunctionDec 6, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: ORANGE PARTICLE IN THE PATIENT CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12934840 ↗MalfunctionNov 16, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: 1 WITH ORANGE PARTICLE IN PATIENT CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12823818 ↗MalfunctionOct 19, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 1 BLUE PARTICLE IN THE PATIENT CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12656525 ↗MalfunctionOct 19, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 2, BLACK PARTICLES ON THE PATIENT CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12656522 ↗MalfunctionOct 12, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: SMALL BLACK PARTICLE ON THE PATIENT CONNECTOR UNDER THE CLOSING CONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12613629 ↗MalfunctionOct 12, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DARK RED PARTICLE IN THE PATIENT CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12613628 ↗MalfunctionSep 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 1 -1 WITH WHITE PARTICLE IN THE PATIENT CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12521285 ↗MalfunctionSep 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 2 -1 WITH SMALL SHINY PARTICLE IN THE TUBING POST FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12521214 ↗MalfunctionAug 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
DURING THE EVALUATION OF THE RETURNED SAMPLES, A PARTICLE WAS OBSERVED AT THE PATIENT CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12355816 ↗MalfunctionJul 26, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY THE USER FACILITY: WE HAVE HAD 4540040-02 INFUSE OVER 15 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12225105 ↗MalfunctionJul 19, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: ORANGE PARTICLE UNDER THE PATIENT SIDE CLOSING CONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12188386 ↗MalfunctionJul 6, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 2 LARGE BLACK PARTICLE UNDER THE CLOSING CONE IN THE PATIENT CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12122586 ↗MalfunctionJul 6, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 1: SMALL ORANGE PARTICLE IN THE PATIENT SIDE CLOSING CONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12122584 ↗MalfunctionJul 6, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY: EVENT 3. BLACK PARTICLE IN THE CLOSING CONE IN THE PATIENT CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12122579 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.