EASYPUMP 4540006-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04046964448454), received between Mar 28, 2017 and May 30, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (17 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ACCORDING TO THE EVENT DESCRIPTION: THE FIRST INCIDENT DELIVERED MEDICATION SEVEN HOURS EARLIER THAN THE ADJUSTED TIME, WHILE THE SECOND INCIDENT DELIVERED IT 17 HOURS EARLIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113392 ↗
• MalfunctionDec 5, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  EVENT 1. ACCORDING TO THE EVENT DESCRIPTION: THERE WERE 4 DIFFERENT PATIENTS WHERE THE EASYPUMP WAS EMPTY AFTER 24 HOURS INSTEAD OF 72 HOURS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20858599 ↗
• MalfunctionDec 5, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  EVENT 3 ACCORDING TO THE EVENT DESCRIPTION: THERE WERE 4 DIFFERENT PATIENTS WHERE THE EASYPUMP WAS EMPTY AFTER 24 HOURS INSTEAD OF 72 HOURS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857748 ↗
• MalfunctionDec 5, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  EVENT 4. ACCORDING TO THE EVENT DESCRIPTION: THERE WERE 4 DIFFERENT PATIENTS WHERE THE EASYPUMP WAS EMPTY AFTER 24 HOURS INSTEAD OF 72 HOURS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20856292 ↗
• MalfunctionDec 5, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  EVENT 2. ACCORDING TO THE EVENT DESCRIPTION: THERE WERE 4 DIFFERENT PATIENTS WHERE THE EASYPUMP WAS EMPTY AFTER 24 HOURS INSTEAD OF 72 HOURS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855133 ↗
• MalfunctionJan 23, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY. DETAILED INQUIRY DESCRIPTION: INFUSION STOPPED AT 12 HRS RATHER THAN 25 HRS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223732 ↗
• MalfunctionJan 23, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILED INQUIRY DESCRIPTION: INFUSION STOPPED AT 12 HRS RATHER THAN 25 HRS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223731 ↗
• MalfunctionJan 23, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: EVENT 3: DETAILED INQUIRY DESCRIPTION: INFUSION STOPPED AT 12 HRS RATHER THAN 25 HRS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223730 ↗
• MalfunctionJan 23, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILED INQUIRY DESCRIPTION: INFUSION STOPPED AT 12 HRS RATHER THAN 25 HRS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223721 ↗
• MalfunctionJan 23, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: EVENT 6: DETAILED INQUIRY DESCRIPTION: INFUSION STOPPED AT 12 HRS RATHER THAN 25 HRS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223720 ↗
• MalfunctionJan 23, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY. EVENT 7. DETAILED INQUIRY DESCRIPTION: INFUSION STOPPED AT 12 HRS RATHER THAN 25 HRS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223719 ↗
• MalfunctionJan 23, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: EVENT 8: DETAILED INQUIRY DESCRIPTION: INFUSION STOPPED AT 12 HRS RATHER THAN 25 HRS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223718 ↗
• MalfunctionJan 23, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: EVENT 5: DETAILED INQUIRY DESCRIPTION: INFUSION STOPPED AT 12 HRS RATHER THAN 25 HRS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223717 ↗
• MalfunctionJan 23, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: EVENT 9: DETAILED INQUIRY DESCRIPTION: INFUSION STOPPED AT 12 HRS RATHER THAN 25 HRS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223716 ↗
• MalfunctionNov 30, 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: "OVERINFUSIONT" "EASYPUMP RUNS EMPTY AFTER 12 HOURS INSTEAD OF 24 HOURS. THE DOCTOR'S OFFICE DISCARDED THE SAMPLE CONTAMINATED WITH CYTO. THE PHARMACY HAS BUT TESTED A SAMPLE WITH NACL, WHICH ALSO RAN TOO FAST. THIS SAMPLE CONTAMINATED WITH NACL CONTAMINATED SAMPLE AND ANOTHER ORIGINAL PACKED SAMPLE ARE SENT IN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12891192 ↗
• MalfunctionNov 30, 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: "OVERINFUSIONT" "EASYPUMP RUNS EMPTY AFTER 12 HOURS INSTEAD OF 24 HOURS. THE DOCTOR'S OFFICE DISCARDED THE SAMPLE CONTAMINATED WITH CYTO. THE PHARMACY HAS BUT TESTED A SAMPLE WITH NACL, WHICH ALSO RAN TOO FAST. THIS SAMPLE CONTAMINATED WITH NACL CONTAMINATED SAMPLE AND ANOTHER ORIGINAL PACKED SAMPLE ARE SENT IN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12891183 ↗
• MalfunctionNov 22, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY USER FACILITY: INFUSIONS ARE ENDING 6 TO 12 HOURS EARLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9365570 ↗
• MalfunctionDec 4, 2018Inaccurate Flow Rate; Inaccurate Flow Rate

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN GERMANY): SOLUTION / FAST FLOW

  Patient problems: No Information

  MAUDE report 8130335 ↗
• MalfunctionOct 31, 2018Inaccurate Flow Rate; Inaccurate Flow Rate

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE: PUMP-FLOW RATE-FAST

  Patient problems: Nausea

  MAUDE report 8025644 ↗
• MalfunctionApr 3, 2017Inaccurate Flow Rate; Inaccurate Flow Rate

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE): PUMP-FLOW RATE-FAST

  Patient problems: No Information

  MAUDE report 6454000 ↗
• MalfunctionMar 28, 2017Inaccurate Flow Rate; Inaccurate Flow Rate

  AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN GERMANY): FAST FLOW

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6440627 ↗