Easypump® 4540010-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04046964448515), received between Nov 1, 2021 and Mar 3, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2024Excess 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: THE 500ML OF SPASFON DEBRIDAT ET PRIMPERAN PASSED MUCH MORE QUICKLY THAN THE ADVERTISED FLOW RATE. DIFFICULT ASSESSMENT ON THE NIGHT OF (B)(6) TO (B)(6) BUT CONNECTION ON (B)(6) 2024 AT 7:30 A.M. AND END OF BROADCAST ON (B)(6) 2024 AT 11 A.M.

  Patient problems: Discomfort

  MAUDE report 18823548 ↗
• MalfunctionMar 1, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY, TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE: WEAR AND TEAR ON THE BALLOON CAUSED THE CHEMOTHERAPY TO DIFFUSE. THE CHEMOTHERAPY THEREFORE LEAKED ONTO THE PATIENT AT HOME. THE OUTER BALLOON WAS TORN IN 2 PLACES. THE LABEL HAS ALSO GIVEN WAY ON CONTACT WITH THE CHEMOTHERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18816770 ↗
• MalfunctionFeb 27, 2024Excess 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 SWITZERLAND: TWO PATIENTS WERE ADMITTED TO THE DEPARTMENT AND THERAPY WAS STARTED FOR THE ONE ON (B)(6) 2024 AT 3 P.M., AND FOR OTHER AROUND 4:35 P.M. THERAPIES ENDED ON (B)(6) 2024 AROUND 10 PM AND THE PATIENTS WERE QUITE RED. THE THERAPY ENDED UP TO 10 HOURS BEFORE THE SCHEDULED TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18794023 ↗
• MalfunctionFeb 27, 2024Excess 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 SWITZERLAND: PM P FLUOROURACIL 3000 MG, 240 ML NACL 0.9% IN EASYPUMP 5ML/H, 270 ML FLEXIBLE, EP USED: BATCH 23H08GED91; EXPIRY: 08/2028. PATIENT L.W. 1954: PUMP FITTED ON (B)(6) 2024 EMPTIED AT 8AM ON 05.01: PATIENT REALISED HER PUMP WAS EMPTY WHEN SHE WOKE UP IN THE MORNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18794021 ↗
• MalfunctionFeb 10, 2023Excess 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: "OVERINFUSION." ACCORDING TO THE CUSTOMER: "THEY HAVE A PROTOCOL OF KETAMINE OF 48MG IN 48ML TO BE PASSED IN 24H IN SUBCUTANEOUS WAY PERI-UMBILICAL. THE DIFFUSER EMPTIES IN 16-17 HOURS. THE NURSE SCRUPULOUSLY RESPECTS ALL THE FILLING RECOMMENDATIONS ATTACHED AND THE PATIENT IS ALSO VIGILANT. THE PROBLEM HAS PERSISTED FOR A WEEK DESPITE VARIOUS ATTEMPTS, EVEN WITH A COMPLETE FILLING. THE KETAMINE IS THEREFORE GIVEN FOR A MUCH SHORTER TIME THAN PRESCRIBED. THE PATIENT DOES NOT FEEL ANY EFFICACY FROM HER TREATMENT BUT NO SIDE EFFECTS EITHER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16358322 ↗
• MalfunctionNov 24, 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 FRANCE: EVENT 1: "PUMP-FLOW RATE-FAST." "2 DIFFUSERS FILLED TO 48ML TO PASS OVER 24 HOURS PASSED IN HALF THE TIME, I.E. 12 HOURS. THE EVENT OCCURRED IN THE SAME PATIENT TWICE. THERE WERE NO CONSEQUENCES FOR THE PATIENT. NO SAMPLE AVAILABLE OCCURENCE DATE : (B)(6) 2021."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12870772 ↗
• MalfunctionNov 24, 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 FRANCE: EVENT 2: "PUMP-FLOW RATE-FAST". "2 DIFFUSERS FILLED TO 48ML TO PASS OVER 24 HOURS PASSED IN HALF THE TIME, I.E. 12 HOURS. THE EVENT OCCURRED IN THE SAME PATIENT TWICE. THERE WERE NO CONSEQUENCES FOR THE PATIENT. NO SAMPLE AVAILABLE OCCURENCE DATE : (B)(6) 2021."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12870769 ↗
• MalfunctionNov 2, 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)(6): "OVERINFUSION". "THEY INSTALLED 24-HOUR DIFFUSERS FOR THE ADMINISTRATION OF ANALGESICS. INDEED, THE PRODUCT WAS DELIVERED TOO QUICKLY. THE PATIENT DID NOT RECEIVE HIS TREATMENT DURING THE EXPECTED DURATION SO HE WAS NOT RELIEVED OF HIS PAIN AS HE SHOULD. THE MEDICATION HAS BEEN ADMINISTRATED PER OS WHEN THE DEFECT HAS BEEN DETECTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739347 ↗
• MalfunctionNov 1, 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)(6): EVENT 2 "OVERINFUSION". "THE CLIENT ENCOUNTERED A PROBLEM IN 2 OF THEIR PATIENTS FOR WHOM THEY INSTALLED 24-HOUR DIFFUSERS FOR THE ADMINISTRATION OF ANALGESICS. INDEED, THE PRODUCT WAS DELIVERED TOO QUICKLY, FOR A DURATION ACCORDING TO THE STATEMENTS OF THE PATIENTS OF 8H, 9H AND 12H INSTEAD OF THE EXPECTED 24 HOURS. THE PATIENT DID NOT RECEIVED HIM TREATMENT DURING THE EXPECTED DURATION SO HE WAS NOT RELIEVED OF HIS PAIN AS HE SHOULD THE MEDICATION HAS BEEN ADMINISTRATED PER OS WHEN THE DEFECT HAS BEEN DETECTED."

  Patient problems: Inadequate Pain Relief

  MAUDE report 12728105 ↗
• MalfunctionNov 1, 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)(6): EVENT 1 "OVERINFUSION" "THE CLIENT ENCOUNTERED A PROBLEM IN 2 OF THEIR PATIENTS FOR WHOM THEY INSTALLED 24-HOUR DIFFUSERS FOR THE ADMINISTRATION OF ANALGESICS. INDEED, THE PRODUCT WAS DELIVERED TOO QUICKLY, FOR A DURATION ACCORDING TO THE STATEMENTS OF THE PATIENTS OF 8H, 9H AND 12H INSTEAD OF THE EXPECTED 24 HOURS. THE PATIENT DID NOT RECEIVED HIM TREATMENT DURING THE EXPECTED DURATION SO HE WAS NOT RELIEVED OF HIS PAIN AS HE SHOULD THE MEDICATION HAS BEEN ADMINISTRATED PER OS WHEN THE DEFECT HAS BEEN DETECTED."

  Patient problems: Inadequate Pain Relief

  MAUDE report 12728101 ↗