EASYPUMP 4540018-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 313 adverse event reports that list this exact device (DI 04046964448638), received between Feb 21, 2017 and Sep 29, 2026 — classified as 6 injuries, 307 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (217 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

Recent adverse event reports

The 25 most recent of 313 reports, 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 50928025 ↗
• 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 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 ↗
• MalfunctionMay 19, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: ACCOUNT FILLED 30 ELASTOMERIC PUMPS YESTERDAY 5/5 FOR USE TODAY, 5/6 AND SAW DROPLETS IN THE TRANSPORT BAGS. THEY RE INSPECTED THEM THIS MORNING AND SAW THAT SEVERAL BAGS HAD ACCUMULATED ADDITIONAL DROPLETS. THEY ALSO SAW FLUID BETWEEN THE INTERIOR BALL AND EXTERIOR BALL. THERE WAS ALSO ONE PUMP THAT HAD WHITE POWDER ON THE FILL PORT, AND THEY SUSPECT THAT THIS IS 5FU. WE HAVE FOUND OUT THEY ARE RECENTLY USING A DIANA REPEATER PUMP TO FILL THE ELASTOMERICS. PATIENT INJURY NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215058 ↗
• MalfunctionMay 19, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: ACCOUNT FILLED 30 ELASTOMERIC PUMPS YESTERDAY 5/5 FOR USE TODAY, 5/6 AND SAW DROPLETS IN THE TRANSPORT BAGS. THEY RE INSPECTED THEM THIS MORNING AND SAW THAT SEVERAL BAGS HAD ACCUMULATED ADDITIONAL DROPLETS. THEY ALSO SAW FLUID BETWEEN THE INTERIOR BALL AND EXTERIOR BALL. THERE WAS ALSO ONE PUMP THAT HAD WHITE POWDER ON THE FILL PORT, AND THEY SUSPECT THAT THIS IS 5FU. WE HAVE FOUND OUT THEY ARE RECENTLY USING A DIANA REPEATER PUMP TO FILL THE ELASTOMERICS. PATIENT INJURY NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215056 ↗
• MalfunctionMay 19, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: ACCOUNT FILLED 30 ELASTOMERIC PUMPS YESTERDAY 5/5 FOR USE TODAY, 5/6 AND SAW DROPLETS IN THE TRANSPORT BAGS. THEY RE INSPECTED THEM THIS MORNING AND SAW THAT SEVERAL BAGS HAD ACCUMULATED ADDITIONAL DROPLETS. THEY ALSO SAW FLUID BETWEEN THE INTERIOR BALL AND EXTERIOR BALL. THERE WAS ALSO ONE PUMP THAT HAD WHITE POWDER ON THE FILL PORT, AND THEY SUSPECT THAT THIS IS 5FU. WE HAVE FOUND OUT THEY ARE RECENTLY USING A DIANA REPEATER PUMP TO FILL THE ELASTOMERICS. PATIENT INJURY NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215055 ↗
• MalfunctionMay 19, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: ACCOUNT FILLED 30 ELASTOMERIC PUMPS YESTERDAY 5/5 FOR USE TODAY, 5/6 AND SAW DROPLETS IN THE TRANSPORT BAGS. THEY RE INSPECTED THEM THIS MORNING AND SAW THAT SEVERAL BAGS HAD ACCUMULATED ADDITIONAL DROPLETS. THEY ALSO SAW FLUID BETWEEN THE INTERIOR BALL AND EXTERIOR BALL. THERE WAS ALSO ONE PUMP THAT HAD WHITE POWDER ON THE FILL PORT, AND THEY SUSPECT THAT THIS IS 5FU. WE HAVE FOUND OUT THEY ARE RECENTLY USING A DIANA REPEATER PUMP TO FILL THE ELASTOMERICS. PATIENT INJURY NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215054 ↗
• MalfunctionMay 7, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: FROM CUSTOMER "FROM WHAT I CAN TELL, IT'S EITHER LEAKING FROM AROUND THE O-RING SEAL NEAR THE INJECTION PORT OR SOMEWHERE ALONG THE INNER BALLOON ITSELF, BUT IT'S SLOW ENOUGH THAT I AM NOT ABLE TO IDENTIFY THE EXACT SPOT". SUBJECT: EASYPUMP LEAK. PATIENT INJURY: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110588 ↗
• MalfunctionMar 12, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: I HAVE A LONG TERM MAINTENANCE PATIENT (4 YEARS) WHO WAS NOTING A FASTER INFUSION SINCE THEY CHANGED THE 5FU PUMPS AND WANTED TO SEE IF OTHER PATIENTS HAVE NOTICED CHANGES. HE REPORTS WITHIN 24 HOURS THE BALL SEEMS MORE EMPTY THAN PRIOR AND HE FEELS DIAPHORETIC THESE DAYS AND SEEMS COMPLETED BY WED AT MIDNIGHT OVER HIS PAST 2 INFUSIONS.

  Patient problems: Diaphoresis

  MAUDE report 24582360 ↗
• MalfunctionMar 12, 2026Leak/Splash

  AS REPORTED BY THE COMPLAINANT: A PATIENT RETURNED FOR THEIR 5FU PUMP DISCONNECT AND THE CARRY CASE WAS WET. CUSTOMER IS CONFIDENT THE PUMP LEAKED BECAUSE 5FU CRYSTALIZES AND THE CARRY CASE HAS THIS FILM AT THE BOTTOM. UPON VISUAL INSPECTION, THERE IS NO APPARENT CAUSE OF THE LEAK (NO HOLE IN THE TUBING, ETC). THERE IS CRYSTALLIZATION AT THE PROXIMAL END OF THE PUMP (OPPOSITE END WHERE FILLED). NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582359 ↗
• MalfunctionMar 12, 2026Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: ELASTOMERIC PUMP (5ML/HR) INFUSED TOO QUICKLY TWICE IN THE SAME PATIENT WHO WAS VERY EDUCATED ON THE PUMP. FIRST INCIDENT INFUSION FINISHED IN 38 HOURS AND WAS SUPPOSED TO BE 46 HOURS FOR 5FU. SECOND INCIDENT THE PUMP EMPTIED AT 19 HOURS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582244 ↗
• MalfunctionFeb 26, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: VISUAL SIGNS OF PUMP LEAKING. HAVE HAD MORE THAN 10 PUMPS WITH THE SAME ISSUES. LEAKING FROM THE END OF TUBING. NO INJURY REPORTED.

  Patient problems: Chemical Exposure

  MAUDE report 24454110 ↗
• MalfunctionFeb 13, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: THE 5FU PUMP WAS PREPARED AND CHECKED BY ONE OUR PHARMACISTS AND WAS THEN PLACED IN THE MEDICATION ROOM FOR THE NURSE TO PICK UP. AT APPROXIMATELY 1230PM, OUR RN CAME TO THE PHARMACY AND SAID THAT HER 5FU BALL WAS LEAKING. UPON EXAMINATION, THE BALL WAS LEAKING THROUGH A HOLE IN THE OUTER MEMBRANE WITH APPROXIMATELY 80-90% OF THE 5FU BALL HAVING EMPTIED ALREADY. THE PRODUCT NEVER REACHED THE PATIENT AND IT WAS REDISPENSED. PATIENT INJURY NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332978 ↗
• MalfunctionFeb 4, 2026Leak/Splash

  ACCORDING TO THE COMPLAINANT, A PATIENT RECEIVED FLUOROURACIL THROUGH A 270 MILLILITER (ML) EASYPUMP AND THE MEDICATION LEAKED OUT OF THE TUBING ONTO HIS BARE CHEST. NO IRRITATION OF THE SKIN OR PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE PATIENT IS DOING FINE.

  Patient problems: Chemical Exposure

  MAUDE report 24257513 ↗
• MalfunctionJan 22, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: ACCORDING TO THE COMPLAINANT, A PATIENT RETURNED TO THE OFFICE FOR PUMP REMOVAL ON (B)(6) 2025, FOLLOWING USE OF A 270 MILLILITER (ML) EASYPUMP DELIVERING 5 ML PER HOUR (ML/HR). DURING REMOVAL, LEAKAGE OF 5-FLUOROURACIL (5-FU) WAS OBSERVED FROM THE VENT OF THE PARTICULATE AND AIR-ELIMINATING FILTER. RESIDUE WAS NOTED AROUND THE VENT AREA OF THE FILTER. THE USER FACILITY REPORTED THAT THE VOLUME OF LEAKED FLUID APPEARED MINIMAL. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152571 ↗
• MalfunctionJan 13, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: 5FU LEAKING OUT OF ELASTOMERIC FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053283 ↗
• MalfunctionDec 23, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: DESCRIPTION: IT WAS A TOTAL VOLUME OF 240 ML. IT WAS LEAKING FROM THE TOP WHERE YOU ADD THE MEDICATION. WHEN I TOOK THE CAP OFF, IT HAD CHEMO COMING OUT FROM IT. IT HAD ONLY BEEN RUNNING ABOUT 12 HOURS OR SO. PATIENT INJURY NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876683 ↗
• MalfunctionDec 10, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1. REASON OF COMPLAINT: I WAS PREPARING A FLUOROURACIL PUMP USING THE EASYPUMP, A 270 ML CAPACITY ML/HR, 54 HR PUMP. AFTER INJECTING AROUND 140 ML OF NORMAL SALINE, I ATTACHED THE ONGUARD 2 CSTD LUER LOCK ADAPTOR AND BEGAN INJECTING AROUND 94 ML OF FLUOROURACIL. AFTER INJECTING APPROXIMATELY 20 MLS OF 5-FU THE DRUG BEGAN TO LEAK FROM WHERE THE SYRINGE AND ADAPTOR WERE ATTACHED. THERE WAS A SLOW DRIP AND APPROXIMATELY 2 MLS LEAKED FROM THE PUMP. I REMOVED THE ONGUARD ADAPTOR AND REPLACED IT WITH A NEW ONE AND THE PUMP CONTINUED TO LEAK. I ALSO ATTEMPTED TO ADD THE DRUG USING A NEW SYRINGE AND ONGUARD SYRINGE ADAPTOR, BUT THE PUMP CONTINUED TO LEAK WHENEVER I ATTEMPTED TO INJECT MORE DRUG. THIS WAS ACTUALLY THE SECOND TIME THIS HAS OCCURRED FOR ME WITH AN EASYPUMP. BOTH TIMES WERE NEARLY IDENTICAL, AFTER PRIMING WITH 10 MLS OF SALINE AND INJECTING ABOUT 150 MLS OF SALINE AND 20 MLS OF 5-FU THE PUMP BEGAN TO LEAK FROM THE DRUG INJECTION SITE. BOTH TIMES I ATTEMPTED TO CONTINUE THE PREPARATION WITH NEW ADAPTORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771633 ↗