EASYPUMP 4540008-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 04046964448485), received between Feb 2, 2017 and Sep 29, 2026 — classified as 54 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (40 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 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928002 ↗
• MalfunctionDec 23, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: EASY PUMP INFUSIONS HAVE BEEN COMPLETING SIGNIFICANTLY EARLIER THAN EXPECTED-ANYWHERE FROM 12 TO 24 HOURS AHEAD OF SCHEDULE. THIS ISSUE HAS BEEN OBSERVED IN AT LEAST THREE TO FOUR PATIENTS, THOUGH THEY MAY BE THE ONLY ONES CLOSELY MONITORING THE PUMPS OVER TIME. THE AFFECTED PATIENTS HAVE CONFIRMED THEY HAVE NOT ENGAGED IN ACTIVITIES THAT COULD ACCELERATE FLOW, SUCH AS EXERCISING, APPLYING PRESSURE TO THE PUMPS, OR EXPOSURE TO HEAT (E.G., WARM WEATHER OR HOT SHOWERS). THE TEAM REPORTS FOLLOWING ALL INTRODUCTORY EDUCATION AND SETUP INSTRUCTIONS PRECISELY, AND THEY ARE UNSURE WHY THIS IS OCCURRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877306 ↗
• MalfunctionMar 18, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE EVENT DESCRIPTION: AN INFUSER RAN OVER 14 HOURS INSTEAD OF 24 HOURS. PATIENT HAD LOOSE STOOLS, WHICH COULD POTENTIALLY BE DUE TO THE DRUG BEING ADMINISTERED TOO FAST, OR COULD BE A SIDE EFFECT FROM OTHER MEDICATION THEY ARE TAKING.

  Patient problems: Diarrhea

  MAUDE report 21631479 ↗
• MalfunctionFeb 12, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  EVENT 1: ACCORDING TO THE EVENT DESCRIPTION: AFTER 6 HOURS THE EASYPUMP WAS ALREADY EMPTY INSTEAD OF THE 24 HOURS. THIS HAS HAPPENED 2 DAYS IN A ROW. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363210 ↗
• MalfunctionFeb 12, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  EVENT 2. ACCORDING TO THE EVENT DESCRIPTION: AFTER 6 HOURS THE EASYPUMP WAS ALREADY EMPTY INSTEAD OF THE 24 HOURS. THIS HAS HAPPENED 2 DAYS IN A ROW. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363209 ↗
• MalfunctionJan 29, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE COMPLAINANT, THE EASYPUMP WAS INFUSING TOO QUICKLY. REPORTEDLY, THE PUMP WAS FILLED WITH FLUOROURACIL (5FU) USING NORMAL SALINE (NS) AS THE DILUENT. THE NOMINAL FILL WAS 240 MILLILITERS (ML). ALTHOUGH THE PUMP SHOULD HAVE INFUSED OVER 24 HOURS, THE CHEMOTHERAPY WAS COMPLETED IN 8 HOURS. THE REPORTED STATED THAT THE "PATIENT HAS BEEN EDUCATED ON THE FACTORS THAT CAN INFLUENCE FLOW RATE (SUCH AS TEMPERATURE AND POSITION OF THE PUMP, ETC.) AND HAS USED EASYPUMP NOW FOR ABOUT 6 MONTHS." NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21267444 ↗
• MalfunctionNov 4, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE EVENT DESCRIPTION: IN A HOSPITAL, NURSING STAFF USED AN EASY PUMP LT270-27 DIFFUSER, BRAUN REFERENCE (B)(4), BATCH 24D20GED41 ON A PATIENT. THE DIFFUSER WAS FILLED WITH 5 FLUOROURACYL FOR A QUANTITY OF 1750MG (MILLIGRAMS) (35 ML (MILLILITERS)), DILUTED IN NACL 0.9% (VOL 192ML). THE INFUSION WAS INITIATED ON (B)(6) 2024 AT 5PM. ON (B)(6) 2024 AT 8:30AM, THE NURSING STAFF NOTICED THAT THE DIFFUSER WAS EMPTY. THE INFUSION THEREFORE LASTED 15 HOURS 30 MINUTES INSTEAD OF THE EXPECTED 22 HOURS. THE DIFFUSER INFUSED MUCH FASTER THAN EXPECTED. THE PATIENT WAS MORE PRONE TO NAUSEA THAN DURING THE PREVIOUS TREATMENT. THE DIFFUSER IS IN QUARANTINE AT THE CUSTOMER'S FACILITY. WE ARE DUE TO COLLECT IT ON WEDNESDAY (B)(6) 2024.

  Patient problems: Vomiting

  MAUDE report 20603750 ↗
• MalfunctionOct 4, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE COMPLAINANT THE PUMP DOES NOT HAVE AN INFUSION TIME OF 27 HOURS AS STATED, BUT APPROXIMATELY 12 HOURS. THE CUSTOMER ALSO SAID THAT THE FLOW RATE OF 10 MILLILITERS AND HOUR (ML/H) DID NOT WORK CORRECTLY FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20368473 ↗
• MalfunctionMay 22, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DESCRIPTION: OUR INFUSION CENTER HAD A PATIENT REPORT LEAKAGE. PATIENT HAD "WET SHIRT" WHEN RETURNED FOR REMOVAL NEXT DAY. THE MORNING OF APPOINTMENT FOR THE PATIENT'S PUMP DISCONNECT PATIENT NOTICED THAT THERE WAS A WET SPOT ON CLOTHING WHEN PATIENT WOKE UP. PATIENT CAME TO CANCER CENTER IMMEDIATELY (4-6 HOURS EARLY FOR SCHEDULED DISCONNECT) WITH PUMP WRAPPED IN A TOWEL. NURSE NOTICED THAT THE TOWEL WAS WET BUT DID NOT SEE THE ACTIVE LEAK. PATIENT STATED THAT LEAK OCCURRED ON TUBING AT JUNCTION WITH DISK MARKED 10 ML/H (JUNCTION CLOSEST TO THE ELASTOMERIC BALL NOT JUNCTION CLOSEST TO PATIENT ACCESS PORT). NO INJURY REPORTED.

  Patient problems: Chemical Exposure

  MAUDE report 16976331 ↗
• MalfunctionMar 22, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  PER MEDWATCH NUMBER MW5115255: DESCRIPTION: PATIENTS SON REPORTED TO NURSE THAT 24 HOURS PIP/TAZ ECLIPSE IS INFUSING COMPLETELY OVER 18-TO 20 HOURS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590105 ↗
• MalfunctionOct 11, 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 AUSTRALIA "OVERINFUSION" PUMP WAS FILLED WITH CEFAZOLIN. PUMP HAS INFUSED TO FAST. NO INFUSION SETTING WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579388 ↗
• MalfunctionOct 11, 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 CHINA "OVERINFUSION." ADMINISTRATION OF 0.9% SODIUM CHLORIDE INJECTION 126 ML + HUMAN ENDOSTATIN INJECTION 3 ML FOR 72 HOURS. THE INFUSION WAS PERFORMED AT 2 ML/HOUR/DAY. AT 13:00 ON AUGUST 26, THE NURSE PREPARED THE PATIENT ACCORDING TO THE ABOVE DOCTOR 'S ADVICE (IT WAS EXPECTED TO END AT 13:00 ON (B)(6). HOWEVER, AT 22:00 ON (B)(6), THE NURSE CHECKED THE INFUSION. NURSE REPORTED THAT INFUSION HAS BEEN FINISHED 15 HOURS EARLIER THAN EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579352 ↗
• MalfunctionOct 7, 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 FRANCE: "PUMP-FLOW-RATE-FAST" "EASYPUMP FILLED TO 120ML FOR DISTRIBUTION OVER 12 HOURS (IN ACCORDANCE WITH THE MANUFACTURER'S RECOMMENDATIONS AND THE PRESCRIPTION). BUT THE INFUSIONS LASTED 5 AND 8 HOURS AFTER THE START. INFUSION STARTED BY THE LIBERAL NURSE AT 6:30 P.M., WITHOUT PROBLEMS. THE PATIENT REALIZED AT 10:30 P.M. THAT THE DIFFUSER WAS PRACTICALLY EMPTY, AN ADDITIONAL 50 ML WAS THEN MADE TO LAST THE NIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15563245 ↗
• MalfunctionJul 8, 2022Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY / TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN AUSTRALIA: "OVERINFUSION" REASON OF COMPLAINT: PUMP RAN EMPTY AFTER 12 HOURS. PUMP FILLED WITH CEFTIAXONE TO INFUSE, OVER 24 HOURS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14960951 ↗
• 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 AUSTRALIA: "OVERINFUSION" REASON OF COMPLAINT: PUMP RAN EMPTY AFTER 13 HOURS. PUMP FILLED WITH CEFTIAXONE TO INFUSE OVER 24 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14960905 ↗
• 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 AUSTRALIA: "OVERINFUSION". ACCORDING TO THE CUSTOMER: "REASON OF COMPLAINT: PUMP RAN OUT IN 14 HOURS RATHER THEN 24 AS FILLED."

  Patient problems: Insufficient Information

  MAUDE report 14958466 ↗
• MalfunctionMay 13, 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 FRANCE: "PUMP-FLOW RATE-FAST". ACCORDING TO THE CUSTOMER: "TOO FAST DIFFUSION WHILE THE DURATION IS SUPPOSED TO BE IN 12H WITH 120 ML. THE NURSE PUTS 150ML AND THE INFUSIONS ALWAYS END BEFORE 12 HOURS. CONSEQUENCES: POTENTIAL OVERDOSE AND POTENTIAL ANTIBIOTIC RESIDUAL PROBLEM."

  Patient problems: Insufficient Information

  MAUDE report 14401660 ↗
• MalfunctionMay 9, 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 (B)(6): "INFUSED TOO FAST". "REASON OF COMPLAINT: WE HAVE HAD AN EASYPUMP RETURNED TO US AS IT WAS COMPLETELY INFUSED OVER 12 HOURS RATHER THAN 24 HOURS. BENZYLPENCILLIN 10.8G IN 240ML."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336868 ↗
• MalfunctionApr 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 (B)(6): "OVERINFUSION" "REASON OF COMPLAINT: WE'VE HAD ANOTHER EASYPUMP RETURNED TO US YESTERDAY WHERE IT WAS REPORTED THAT IT INFUSED TOO QUICKLY. PATIENT WAS CONNECTED AT APPROX. 1600 HOWEVER EASYPUMP WAS FOUND TO BE EMPTY BY THE NURSE AT 1200PM NEXT DAY. PATIENT'S WIFE THEN REPORTED THAT IT WAS ALREADY EMPTY AT 0700."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14053398 ↗
• MalfunctionFeb 26, 2022Improper Flow or Infusion; Improper Flow or Infusion

  AS REPORTED BY THE USER FACILITY / TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE: "PUMP-FLOW RATE-FAST." "CONNECTION AT 5 P.M. (B)(6) 2022) - INFUSION STOP AT 3 A.M. (B)(6) 2022). FILLING OF THE DIFFUSER BY THE LIBERAL NURSE, MEANS OF FILLING: SYRINGE. VISIBLE AIR BUBBLES OR KINKS IN THE TUBING: NO. AMBIENT TEMPERATURE. CATHETER LOCATION: FOREARM AND NON-POSITIONAL. LOCATION OF THE DIFFUSER: BELT BAG AT THE SAME LEVEL AS THE CATHETER, EXCLUDING CLOTHING AND BLANKET. DRUG: ACUPAN. THE DIFFUSER ADMINISTERED THE 240ML OVER 10H INSTEAD OF 24H, DESPITE GOOD FILLING OF THE IDEL (240ML). THE INCIDENT OCCURRED WITH ALL INFUSIONS SINCE D1 FRIDAY (B)(6) 2022. PATIENT CONSEQUENCES: BLOOD PRESSURE DISORDERS, PALPITATIONS, FEELING OF DISCOMFORT (NO DIGESTIVE DISORDERS) AT THE END OF THE INFUSION AND THEN RAPID RECOVERY IN A FEW HOURS."

  Patient problems: High Blood Pressure/ Hypertension; Low Blood Pressure/ Hypotension

  MAUDE report 13608316 ↗
• MalfunctionJan 11, 2022Improper Flow or Infusion; Improper Flow or Infusion

  AS REPORTED BY THE USER FACILITY / TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6): "PUMP-AIR INLET." "WEEK 51 DURING THE DAY / 5 MINUTES AFTER START OF ADMINISTRATION (PRIMPERAN) WITH DIFFUSER, CHEST PAIN. EMERGENCY CONSULTATION - PULMONARY EMBOLISM DIAGNOSIS - TREATMENT ADMINISTERED - RETURN HOME - NURSES DO A TEST ON A DIFFUSER WITHOUT CONNECTION TO THE PATIENT (PRIMPERAN) - AIR BUBBLE OBSERVATION - THE AIR FILTER IS DEFECTIVE."

  Patient problems: Pain; Pulmonary Embolism

  MAUDE report 13227193 ↗
• MalfunctionOct 5, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT WHEN SHE WAS ADDING NS TO THE PUMP IN THE CLEAN ROOM A SMALL PARTICLE MOVED THROUGH THE TUBING AND IS LODGED IN THE END CAP. STATES PARTICLE RESEMBLED A SMALL PIECE OF CARDBOARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12577600 ↗
• MalfunctionSep 10, 2021Excess 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 (B)(4): "OVERINFUSION" "EASYPUMP HAS BEEN RUNNING FOR 17 HOURS INSTEAD OF 48 HOURS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453622 ↗
• MalfunctionAug 4, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY USER FACILITY: AN ELASTOMERIC DEVICE RAN TOO FAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12273803 ↗
• MalfunctionDec 1, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY USER FACILITY: PUMP FILLED WITH PIPERACILLIN/TAZOBACTAM 13.5G/140ML NS, FINISHED BETWEEN 12-18 HOURS INSTEAD OF 24.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10929193 ↗