Easypump® 4540032-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04046964448843), received between Feb 25, 2022 and Aug 7, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionFeb 24, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE EVENT DESCRIPTION: INFUSION PLANNED OVER 96 HOURS. ACCORDING TO THE REPORT, THE PUMP WAS ALMOST EMPTY MORE THAN 24 HOURS BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21448343 ↗
• MalfunctionFeb 19, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE CUSTOMER: "THE PUMP DELIVERED 5FU IN 72 HOURS INSTEAD OF THE SCHEDULED 96 HOURS. FOR YOUR INFORMATION, THE PATIENT HAD A FEVER BUT TREATMENT WAS INTERRUPTED DURING THE FEVER EPISODE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409871 ↗
• MalfunctionJan 16, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE CUSTOMER FACILITY: "PATIENT HAS A 7-DAY PUMP WITH FLUOROURACIL (5FU) AND COMES TO CHANGE TO A NEW 7-DAY PUMP ON THIS DAY. THE PATIENT SAYS THAT THE PUMP WAS ALREADY EMPTY AFTER 3 DAYS. THIS CANNOT REALLY BE VERIFIED. THE PATIENT SAID SHE FELT A LITTLE NAUSEOUS, BUT OTHERWISE DID NOT NOTICE MUCH. SHE WAS ALSO UNABLE TO SAY EXACTLY WHEN THE PUMP WAS EMPTY. THIS MEANS THAT ULTIMATELY IT REMAINS UNCLEAR WHETHER THE PUMP WAS REALLY EMPTY AFTER 3 DAYS. WE ADVISED HER TO CONTACT US IMMEDIATELY IF THIS SHOULD HAPPEN AGAIN. ACCORDING TO THE LABEL, THE PUMP HAD BEEN FILLED CORRECTLY. SERIOUS POSSIBLE CONSEQUENCES: IF THE PUMP REALLY WAS EMPTY AFTER 3 DAYS, THIS COULD LEAD TO INCREASED SIDE EFFECTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21167801 ↗
• MalfunctionJan 7, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION ON (B)(6) PT RECEIVED AN EASYPUMP INTENDED FOR 5-DAY INFUSION. ON (B)(6) PATIENT EXPERIENCED NAUSEA AND DIZZINESS AND WAS ADMITTED TO THE HOSPITAL & SHOWED SIGNS OF SEPSIS. DETAILED INQUIRY DESCRIPTION ON (B)(6) PT RECEIVED AN EASYPUMP INTENDED FOR 5-DAY INFUSION. ON (B)(6) PATIENT EXPERIENCED NAUSEA AND DIZZINESS AND WAS ADMITTED TO THE HOSPITAL & SHOWED SIGNS OF SEPSIS. ONC NURSE DISCONNECTED PUMP (B)(6) AND STATED PUMP WAS EMPTY AFTER 48HRS. PT WAS IN ICU UNTIL WEDNESDAY. SEE ATTACHED NOTE: ON (B)(6) PT RECEIVED AN EASYPUMP INTENDED FOR 5-DAY INFUSION. ON (B)(6) PATIENT EXPERIENCED NAUSEA AND DIZZINESS AND WAS ADMITTED TO THE HOSPITAL & SHOWED SIGNS OF SEPSIS. ONC NURSE DISCONNECTED PUMP (B)(6) AND STATED PUMP WAS EMPTY AFTER 48HRS. PT WAS IN ICU UNTIL WEDNESDAY.

  Patient problems: Dizziness; Nausea; Sepsis

  MAUDE report 21090892 ↗
• MalfunctionAug 18, 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 PERU: "OVERINFUSION." "270 ML NOMINAL CAPACITY OF MORPHINE WITH DIMETOCLOPRAMIDE, HOWEVER THE INFUSION WAS DELIVERED AT AN EXCESSIVE RATE THAN AT AFTER 30 HOURS OF OPERATION, THE RESPECTIVE THERAPY IS FINISHED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254896 ↗
• 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 GERMANY: "OVERINFUSION" ACCORDING TO THE CUSTOMER: "EASYPUMP LT 2ML/H 270ML, CH.REF. (B)(4). THE EASYPUMP FROM THE MENTIONED BATCH WAS SUPPOSED TO RUN FOR 5 DAYS (120H), FILLING 240ML WITH 5-FU/ NACL 0.9%. HOWEVER, AFTER ABOUT 3 DAYS THE PUMP WAS COMPLETELY EMPTY. NO USER ERRORS ARE APPARENT, ACCORDING TO CONSULTATION THE PATIENT DID NOT "LIE ON" THE PUMP OR OTHERWISE EXERT PRESSURE ON THE PUMP."

  Patient problems: Insufficient Information

  MAUDE report 14958285 ↗
• MalfunctionMar 30, 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): EVENT 2 "OVERINFUSION" "ON 2 PUMPS OF THE BATCH 21F23GE341 THE PUMP RAN THROUGH MUCH TOO FAST. FOR BOTH PATIENTS, THE PUMP WAS ATTACHED ON FRIDAY MORNING AND FOR ONE PATIENT IT HAD ALREADY RUN THROUGH ON SUNDAY AT 8:00 A.M. AND FOR THE OTHER IT HAD ALREADY RUN THROUGH ON SATURDAY EVENING. WE GOT BOTH PUMPS BACK FROM THE STATION AND COULD SEND THEM TO YOU."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13952289 ↗
• MalfunctionMar 30, 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): EVENT 1 "OVERINFUSION" "ON 2 PUMPS OF THE BATCH 21F23GE341 THE PUMP RAN THROUGH MUCH TOO FAST. FOR BOTH PATIENTS, THE PUMP WAS ATTACHED ON FRIDAY MORNING AND FOR ONE PATIENT IT HAD ALREADY RUN THROUGH ON SUNDAY AT 8:00 A.M. AND FOR THE OTHER IT HAD ALREADY RUN THROUGH ON SATURDAY EVENING. WE GOT BOTH PUMPS BACK FROM THE STATION AND COULD SEND THEM TO YOU."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13952277 ↗
• MalfunctionFeb 25, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: EVENT 2: SAME FEMALE PATIENT HAD TWO INCIDENCES OF OVER INFUSION OF 5-FU, ENDED EARLY. INCIDENT TWO INFUSION STARTED (B)(6) 2022 AT 2 PM ENDED (B)(6) 2022 8 AM, EXPECTED TO BE 96-HOUR INFUSION, VOLUME IN PUMP 192 ML DOSE 3200 MG. UNKNOWN IF PATIENT HAD ANY ISSUES AS NOT DOCUMENTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13599992 ↗
• MalfunctionFeb 25, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: EVENT 1: SAME FEMALE PATIENT HAD TWO INCIDENCES OF OVER INFUSION OF 5-FU, ENDED EARLY. INCIDENT ONE STARTED (B)(6) 2022 AT 3:40 PM FINISHED (B)(6) 2022 11:30 PM. EXPECTED TO BE 96-HOUR INFUSION. VOLUME IN PUMP 192 ML DOSE 4800 MG. PATIENT DEVELOPED MUCOSITIS - INTERVENTIONS REQUIRED UNKNOWN.

  Patient problems: Inflammation

  MAUDE report 13599936 ↗