EASYPUMPRecalls & reported problems across all models
B. Braun Medical Inc. · 12 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 498
- Deaths reported
- 1
- Injuries reported
- 7
- Recalls
- 0
We found 12 models of EASYPUMP by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 498 adverse event reports in the FDA's MAUDE database, received between Feb 2, 2017 and Sep 29, 2026 — classified as 1 death, 7 injuries, 490 malfunctions.
The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (314 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported EASYPUMP problems
Device problems
- Excess Flow or Over-Infusion314
- Leak/Splash83
- Contamination /Decontamination Problem36
- Inaccurate Flow Rate36
- Fluid/Blood Leak19
- Air/Gas in Device3
- Improper Flow or Infusion3
- Device Contaminated During Manufacture or Shipping2
Patient problems
- No Clinical Signs, Symptoms or Conditions275
- No Known Impact Or Consequence To Patient79
- No Consequences Or Impact To Patient51
- Discomfort13
- Chemical Exposure12
- Nausea10
- No Information10
- Malaise9
EASYPUMP models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EASYPUMP 4540018-02PUMP, INFUSION, ELASTOMERIC313 reports
- EASYPUMP 4540008-02PUMP, INFUSION, ELASTOMERIC54 reports
- EASYPUMP 4540040-02PUMP, INFUSION, ELASTOMERIC1 death41 reports
- EASYPUMP 4540006-02PUMP, INFUSION, ELASTOMERIC21 reports
- Easypump® 4540016-02Pump, infusion, elastomeric19 reports
- EASYPUMP 4540046-02PUMP, INFUSION, ELASTOMERIC15 reports
- Easypump® 4540032-02Pump, infusion, elastomeric12 reports
- Easypump® 4540010-02Pump, infusion, elastomeric10 reports
- EASYPUMP 4540050-02PUMP, INFUSION, ELASTOMERIC8 reports
- EASYPUMP 4540058-02PUMP, INFUSION, ELASTOMERIC3 reports
- EASYPUMP 4540044-02PUMP, INFUSION, ELASTOMERIC1 report
- EASYPUMP 4540056-02PUMP, INFUSION, ELASTOMERIC1 report
Recent EASYPUMP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928029 ↗MalfunctionSep 29, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928025 ↗MalfunctionSep 29, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928002 ↗MalfunctionSep 8, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50669904 ↗MalfunctionAug 19, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50321719 ↗MalfunctionAug 19, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50321718 ↗MalfunctionAug 7, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50172841 ↗MalfunctionAug 7, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50172840 ↗MalfunctionAug 6, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50161499 ↗MalfunctionAug 6, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50161498 ↗MalfunctionJul 27, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50045648 ↗MalfunctionJul 1, 2026Excess Flow or Over-Infusion
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: WE ARE CURRENTLY USING EASYPUMP ELASTOMERIC INFUSION PUMP II LT 270-54-S. (PRODUCT NUMBER 4540018-02; LOT NUMBER 25B01GE561) TO ADMINISTER FLUOROURACIL INFUSIONS FOR AN ONCOLOGY PATIENT. THE PATIENT HAS REPORTED THAT HIS FLUOROURACIL INFUSIONS HAVE COMPLETED SIGNIFICANTLY EARLIER THAN EXPECTED ON MULTIPLE OCCASIONS, WITH THE BULB EMPTYING APPROXIMATELY 12-17 HOURS AHEAD OF THE SCHEDULED COMPLETION TIME. I SPOKE DIRECTLY WITH THE PATIENT REGARDING POTENTIAL FACTORS THAT COULD AFFECT THE INFUSION RATE. HE REPORTS THAT HE DOES NOT EXPOSE THE DEVICE TO EXTREME TEMPERATURES, DOES NOT LIE ON OR COMPRESS THE BULB, AND GENERALLY HANDLES THE DEVICE WITH GREAT CARE. BASED ON OUR DISCUSSION, THERE DO NOT APPEAR TO BE ANY OBVIOUS ISSUES RELATED TO DEVICE HANDLING OR STORAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25677449 ↗InjuryJun 19, 2026Excess Flow or Over-Infusion
AS REPORTED ON MW5096817: PATIENT SCHEDULED ON (B)(6) 2020 FOR FOLFOX CHEMOTHERAPY. THE 46-HOUR TAKE HOME FLUOROURACIL DOSE WAS COMPOUNDED IN A B BRAUN EASYPUMP ELASTOMERIC DEVICE (270-54-S). THE CORRECT DRUG, THE CORRECT DRUG AND BASE SOLUTION VOLUME AND CORRECT SIZE/RATE ELASTOMERIC DEVICE WAS USED TO PREPARE THE 5FU DOSE FOR THIS PATIENT AS CONFIRMED IN THE COMPOUNDING CAMERA IMAGES. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 WITH RECTAL BLEEDING. LAB TESTS RESULTED PLT OF 9. AT 4PM ON (B)(6) 2020, IT WAS ALSO NOTED IN THE HOSPITALIZATION RECORD THAT THE ELASTOMERIC DEVICE WAS EMPTY. THE ELASTOMERIC DEVICE CONTAINING CHEMOTHERAPY SET TO INFUSE OVER 46 HOURS WAS ATTACHED ON (B)(6) 2020 AT 1148AM. THE DEVICE HAS AN ACCURACY OF INFUSION DURATION +/- 15% AND SHOULD HAVE ENDED BETWEEN 448AM AND 348PM ON (B)(6) 2020. THE ELASTOMERIC RAN TO FAST AND EMPTIED 11 HOURS EARLY. FDA SAFETY REPORT ID # (B)(4). AS PART OF AN INTERNAL NONCONFORMANCE, THIS IMPORTER MDR IS BEING SUBMITTED RETROACTIVELY. PLEASE NOTE THAT THE ASSOCIATED MANUFACTURER MDR FOR THIS EVENT, 9610825-2020-00261, HAD ALREADY BEEN PREVIOUSLY SUBMITTED TIMELY ON 23OCT2020. AS B. BRAUN MEDICAL, INC. SUBMITTED THE
Patient problems: Gastrointestinal Hemorrhage
MAUDE report 25563525 ↗InjuryJun 19, 2026Excess Flow or Over-Infusion
AS REPORTED BY THE USER FACILITY: PUMP INFUSED FASTER THAN EXPECTED, WHILE PATIENT WAS AT HOME. CUSTOMER THINKS TEMPERATURE MAY HAVE AFFECTED THE INFUSION. "THE PATIENT IS A 64-YEAR OLD MALE. THE MEDICATION WAS FLUOROURACIL. THE PATIENT WAS ACTUALLY BEING SEEN IN OUR EMERGENCY DEPARTMENT DUE TO WEAKNESS/STEMI AND THE CHEMO NURSE WAS ASKED TO COME DISCONNECT THE IV PUMP AND SHE REPORTED IT WAS COMPLETELY DONE INFUSING. THE PUMP HAD BEEN STARTED 1/26 AROUND 2 PM AND THE NURSE REMOVED THE PUMP WHILE THE PATIENT WAS IN THE ED ON 1/27 AROUND 6:30-7 PM. SO THE PUMP MAYBE INFUSED OVER AROUND 30 HOURS AND WAS SUPPOSED TO GO FOR 46 HOURS." AS PART OF AN INTERNAL NONCONFORMANCE, THIS IMPORTER MDR IS BEING SUBMITTED RETROACTIVELY. PLEASE NOTE THAT THE ASSOCIATED MANUFACTURER MDR FOR THIS EVENT, 9610825-2022-00029, HAD ALREADY BEEN PREVIOUSLY SUBMITTED TIMELY ON 21FEB2022. AS B. BRAUN MEDICAL, INC. SUBMITTED THE MANUFACTURER MDR ON BEHALF OF THE MANUFACTURER, THE IMPORTER MDR WAS INADVERTENTLY MISSED.
Patient problems: Muscle Weakness/Atrophy; Pericarditis
MAUDE report 25563335 ↗MalfunctionJun 8, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2 LEAKING ELASTOMERIC
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25429509 ↗
Other B. Braun Medical Inc. products
- Infusomat54 models · 2,783 reports · 30 recalls
- IV Administration Set153 models · 281 reports · 68 recalls
- Hemodialysis Bloodlines9 models · 2,179 reports · 14 recalls
- Outlook25 models · 195 reports · 24 recalls
- Perifix57 models · 224 reports · 20 recalls
- Extension Set41 models · 101 reports · 16 recalls
- Design Options116 models · 132 reports · 14 recalls
- Blood Administration Set24 models · 177 reports · 13 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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