EASYPUMP 4540050-02Recalls & reported problems
B. Braun Medical Inc. · Easypump® ST 250-1.5-S · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04046964449093), received between Jul 26, 2017 and May 15, 2023 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (5 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.
Most reported problems
Device problems
- Excess Flow or Over-Infusion5
- Inaccurate Flow Rate2
- Improper Flow or Infusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY THE USER FACILITY, DETAILED INQUIRY DESCRIPTION, IT WAS REPORTED THAT THE EASYPUMP INFUSED TOO QUICKLY. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16929634 ↗MalfunctionFeb 8, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY THE USER FACILITY: OVERINFUSION. PATIENT STATED THAT THE DEVICE INFUSED IN BETWEEN 20-30 MINUTES. CLINICAL PHARMACIST DID VERIFY THAT HER HOUSE TEMPERATURE WAS SET AT 68 DEGREES AND SHE WAS NOT SITTING UNDER BLANKETS OR HANGING IT UP HIGH TO INFUSE. I HAVE INCLUDED MY ANSWERS IN RED BELOW. THE MEDICATION INFUSING AT THE TIME WAS VANCOMYCIN 1500 MG/250 ML IN NS IN THE 250 ML DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13480331 ↗MalfunctionDec 2, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY THE USER FACILITY: OVERINFUSION. PATIENT STATED THAT DEVICES INFUSED BETWEEN 20-30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12918949 ↗MalfunctionDec 2, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY THE USER FACILITY: OVERINFUSION. PATIENT STATED THAT DEVICE INFUSED BETWEEN 20-30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12918863 ↗MalfunctionDec 2, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY THE USER FACILITY: OVERINFUSION. PATIENT STATED THAT DEVICE INFUSED BETWEEN 20-30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12918789 ↗MalfunctionApr 20, 2021Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED BY THE END USER: I AM HELPING MY DAUGHTER WITH HER EASYPUMP INFUSION AND I NOTICED TODAY THAT THERE ARE AIR BUBBLES IN THE TUBING STARTING WERE THE EASYPUMP CONNECTS TO THE EXTENSION SET. THERE ARE NOT ANY BUBBLES UP-STREAM FROM THE CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11692547 ↗MalfunctionAug 8, 2017Inaccurate Flow Rate; Inaccurate Flow Rate
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE): PUMP-FLOW RATE-FAST
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6773224 ↗MalfunctionJul 26, 2017Inaccurate Flow Rate; Inaccurate Flow Rate
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE): PUMP-FLOW RATE-FAST
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6744672 ↗
Other PUMP, INFUSION, ELASTOMERIC devices
- EASYPUMP 4540018-02B. Braun Medical Inc. · PUMP, INFUSION, ELASTOMERIC313 reports
- Halyard 13568Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC86 reports
- ON-Q* Pain Relief System with SELECT-A-FLOW 13472Avanos Medical, Inc. · Pump, infusion, elastomeric73 reports
- Halyard 13472Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC68 reports
- EASYPUMP 4540008-02B. Braun Medical Inc. · PUMP, INFUSION, ELASTOMERIC54 reports
- DOSI-FUSER L25915-500D1-USALeventon Sau · Pump, Infusion, Elastomeric1 recall0 reports
- DOSI-FUSER L25915-600D1-USALeventon Sau · Pump, Infusion, Elastomeric1 recall0 reports
- Halyard 13561Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC42 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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