Easypump® 4540016-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04046964448607), received between Jul 8, 2022 and Sep 29, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (8 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 19 most recent of 19 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 50928029 ↗
• 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 ↗
• MalfunctionJun 8, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1 LEAKING ELASTOMERIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429508 ↗
• MalfunctionJun 8, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 3 LEAKING ELASTOMERIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429502 ↗
• MalfunctionMay 20, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: LEAKING ELASTOMERICWE ARE HAVING ISSUES WHEN FILLING THESE PUMPS. SOME LEAK IN A SPECTACULAR FASHION AT THE FILL PORT WHEN ADDING DRUG/SALINE. WE'VE TRIED TO ESTABLISH WHETHER IT'S THE SYRINGES OR THE PUMPS BUT HAVE NOT BEEN ABLE TO RULE EITHER OUT. WE STARTED USING ALL THE SAME SIZE/MANUFACTURER SYRINGES AND DIDN'T HAVE ANY ISSUES FOR SEVERAL DAYS BUT IT HAPPENED AGAIN TODAY. IT'S HAPPENED 6-8 TIMES AND I'VE SAVED 3 OF THE PUMPS. THE PUMPS HAVE BEEN FILLED WITH FLUOROURACIL. PATIENT INJURY NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233645 ↗
• MalfunctionApr 21, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: WE RECENTLY DISCHARGED A PATIENT WITH A 5-FLUOROURACIL INFUSION BULB, WHO RETURNED TODAY DUE TO LEAKAGE. UPON INSPECTION, IT APPEARS THE LEAK ORIGINATED AT THE SEAL BETWEEN THE CAP AND THE BULB ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24939975 ↗
• MalfunctionJun 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINANT REPORTED THAT THE EASYPUMP DID NOT INFUSE WHILE CONNECTED TO THE PATIENT. AFTER DISCONNECTION, THE DEVICE WAS RETURNED TO THE PHARMACY, WHERE IT WAS FOUND TO HAVE LEAKED CHEMOTHERAPY UNDER THE HOOD. THE FACILITY INDICATED THAT THE END OF THE LINE HAD A CLOSED SYSTEM, SPECIFICALLY, A CHEMOCLAVE¿. ADDITIONAL INFORMATION REVEALED THAT THE PATIENT WAS FAMILIAR WITH THE SYSTEM, AS THIS WAS THEIR SEVENTH TREATMENT CYCLE. WHEN THE PATIENT RETURNED, THE PUMP WAS FULL, ALL CLAMPS WERE OPEN, AND THE TUBING HAD BEEN TAPED TO THE PATIENT AS PER STANDARD PRACTICE. REPORTEDLY, THE DEVICE HAD BEEN LEFT UNDER THE CHEMO HOOD WITH THE CLOSED SYSTEM CAP IN PLACE. THE PATIENT DID NOT RECEIVE THE PRESCRIBED DOSE OF FLUROURACIL (5-FU). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174856 ↗
• MalfunctionJun 6, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: EASYPUMP MEDICATION GETS DONE EARLY. DETAILED INQUIRY DESCRIPTION: (B)(6) IS USING EASYPUMP AND HAS SEEN AN INCREASE IN COMPLAINTS ON THE MEDICATION FINISHING EARLY (UP TO 12 HOURS). I HAVE SENT THE VIDEO OVER AS WELL AS TIPS/TRICKS FOR THE PATIENT. THEY HAVE THE PATIENT INFORMATION CARDS AND USE THE INSULATED POUCHES FOR ALL PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22160419 ↗
• MalfunctionMar 18, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE EVENT DESCRIPTION: THE EASYPUMP RAN THROUGH IN 22 HOURS INSTEAD OF 50 HOURS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634982 ↗
• MalfunctionMar 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE CUSTOMER FACILITY: "THE PUMP LEAKED ON THE PATIENT AND WAS RETURNED. THERE IS PROBABLY A LEAK IN THE PUMP OR THE ASSOCIATED HOSE. THE DROPS WERE CLEARLY VISIBLE AT THE CONNECTION POINT BETWEEN THE PUMP AND THE TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595077 ↗
• MalfunctionDec 6, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE EVENT DESCRIPTION: THE INFUSER WAS CONNECTED AT 1PM ON (B)(6) 2024, AND AT 11AM ON (B)(6) 2024 THE HOMECARE NURSE WAS CONTACTED BECAUSE THE PATIENT HAD NOTICED THAT HIS INFUSER HAD BEEN EMPTY FOR AT LEAST 3 HOURS. MEDICATION: 5 FU + GLUCOSE 17.188 MILLIGRAMS PER MILLILITER (MG/ML), FILLING VOLUME: 96 ML - FLOW RATE 2ML LH. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 20863590 ↗
• MalfunctionNov 26, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE EVENT DESCRIPTION: FIRST INSTALLATION ON A PATIENT, DIFFUSER CONNECTED AT 3PM ON (B)(6) 2024, WAS EMPTY THIS MORNING. EVERY PRECAUTION WAS TAKEN TO AVOID THIS SITUATION. THE PATIENT IS EXPERIENCING UNDESIRABLE EFFECTS THAT WILL BE DETRIMENTAL TO THE CONTINUATION OF HIS TREATMENT.

  Patient problems: Discomfort

  MAUDE report 20789689 ↗
• MalfunctionNov 21, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE EVENT DESCRIPTION: THE PATIENT HAD ALREADY STATED THAT HER PUMP OF (B)(6) 2024 HAD GONE TO 31 HOURS INSTEAD OF 48 HOURS. REPORTEDLY THE PATIENT WAS GIVEN INFORMATION ON PROPER USE OF THE INFUSER AT HOME. SHE RETURNS FOR HER TREATMENT ON (B)(6) 2024 AND HER PUMP OF OCTOBER 4 WENT FROM 1:30 P.M. TO 3:35 P.M., SO IN 26 HOURS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 20750456 ↗
• MalfunctionNov 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: EASYPUMP LEAKING AT FILTER. DETAILED INQUIRY DESCRIPTION: PT REPORTED LEAKING OF 5FU FROM EASYPUMP. LEAKAGE NOTED AT FILTER AND CHEMO RESIDUE SEEN IN CARRY POUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20665030 ↗
• MalfunctionJun 6, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED BY THE USER FACILITY: EVENT 2 BRIEF INQUIRY DESCRIPTION EASY PUMP DIDN'T FLOW DETAILED INQUIRY DESCRIPTION WE HAD TWO EASY PUMPS 100ML 2ML/HOUR THAT DID NOT INFUSE ANY OF ITS CONTENTS THIS WEEK. THE LOT NUMBER WAS 23E19GE551. THE ISSUE APPEARS TO BE A BLOCKAGE IN THE TUBING JUST BELOW THE FILTER. THERE IS A SMALL WHITE PIECE INSIDE THE TUBING THAT I GUESS IS DRIED EXCESS GLUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477050 ↗
• MalfunctionJun 6, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED BY THE USER FACILITY: EVENT 1 BRIEF INQUIRY DESCRIPTION EASY PUMP DIDN'T FLOW DETAILED INQUIRY DESCRIPTION WE HAD TWO EASY PUMPS 100ML 2ML/HOUR THAT DID NOT INFUSE ANY OF ITS CONTENTS THIS WEEK. THE LOT NUMBER WAS 23E19GE551. THE ISSUE APPEARS TO BE A BLOCKAGE IN THE TUBING JUST BELOW THE FILTER. THERE IS A SMALL WHITE PIECE INSIDE THE TUBING THAT I GUESS IS DRIED EXCESS GLUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477049 ↗
• MalfunctionApr 30, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: LEAKING DURING 5FU INFUSION WITH EASYPUMP. DETAILED INQUIRY DESCRIPTION: "WE HAD A PATIENT THAT EXPERIENCED A LEAK WITH HIS 5FU PUMP. I S/W THE PATIENT YESTERDAY EVENING AND THEY INDICATED THERE WAS A WHITE RESIDUE ALL OVER THEIR BLACK BAG AND THAT IT WAS DAMP. I INSTRUCTED THEM TO PUT IT INTO THE CHEMOTHERAPY BAG AND CLOSE THE BAG TO THE TUBING AND LET IT CONTINUE TO RUN POSITIONING TO ENSURE NO DRUG COULD LEAK FROM THE BAG--IF THEY NOTICED DRUG POOLING IN THE BAG-CLAMP IT AND COME IN FIRST THING. I S/W THE PATIENT AT 8AM AND THEY SAID THERE WAS JUST DROPS IN THE BAG." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217406 ↗
• MalfunctionApr 22, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: LEAKING OF 5FU FROM RESERVOIR. DETAILED INQUIRY DESCRIPTION CUSTOMER REPORTED 5FU WAS SLOW LEAKING, AS IF "WEEPING" OUT OF THE BODY OF THE ELASTOMERIC. 5FU LEAKED TO EASYPUMP CARRY POUCH. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19159714 ↗
• MalfunctionJul 8, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY / TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN DENMARK: "OVERINFUSION" REASON OF COMPLAINT: 2 COMPLAINTS FROM THE SAME PATIENT. THE PUMP WAS SUPPOSED TOO BE EMPTY AFTER 46 HOURS, BUT IT WAS EMPTY AFTER 24 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14958110 ↗