EASYPUMP 4540046-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04046964449031), received between Mar 1, 2018 and Apr 19, 2023 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: ELASTOMERIC PUMPS DELIVERING MEDICATION TOO QUICKLY. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16767965 ↗
• MalfunctionDec 2, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: OVERINFUSION: PATIENT STATED THAT DEVICE WAS INFUSING BETWEEN 20-30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916032 ↗
• MalfunctionDec 2, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: OVERINFUSION. PATIENT STATED THAT DEVICE WAS INFUSING BETWEEN 20-30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916031 ↗
• MalfunctionDec 2, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: OVERINFUSION: PATIENT STATED THAT DEVICE WAS INFUSING BETWEEN 20-30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12915999 ↗
• MalfunctionApr 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: LEAKING FROM FILTER. PUMP CONTAINED GANCICLOVIR. LEAKAGE WAS NOTICED RIGHT AFTER PATIENT OPENED CLAMP. PATIENTS ARE TAUGHT TO WEAR GLOVES WHEN STARTING THIS MEDICATION SO POTENTIAL EXPOSURE IS LIMITED AS PATIENT NOTED LEAK IMMEDIATELY. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7429304 ↗
• MalfunctionMar 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: 1 SAMPLE OF EASY PUMP LEAKED DURING COMPOUNDING OF GANCICLOVIR (CYTOTOXIC AGENT). SAMPLE DISPOSED OF IN ACCORDANCE WITH HAZARDOUS SUBSTANCE PROTOCOLS. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7344815 ↗
• MalfunctionMar 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: ONE SAMPLE OF EASYPUMP LEAKED DURING COMPOUNDING OF GANCICLOVIR (CYTOTOXIC AGENT). SAMPLE DISPOSED OF IN ACCORDANCE WITH HAZARDOUS SUBSTANCE PROTOCOLS. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7344809 ↗
• MalfunctionMar 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: EVENT 4: THE PUMP IS LEAKING DURING FILLING / IMMEDIATELY AFTER FILLING IN AN ISO CLASS 5 HOOD WITHIN AN ISO CLASS 7 SUITE. THE TECHNICIANS NOTED IT APPEARS THEY MAY BE CRACKED ON THE TOP AND THAT THEY ARE LEAKING WHERE THEY LUER TO THE DEVICE TO FILL IT WITH DRUG/DILUENT. THE DEFECT WAS NOTED WHEN THE TECHNICIAN ATTEMPTED TO ADD GANCICLOVIR (CYTOTOXIC AGENT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7344806 ↗
• MalfunctionMar 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: EVENT 1: THE PUMP IS LEAKING DURING FILLING / IMMEDIATELY AFTER FILLING IN AN ISO CLASS 5 HOOD WITHIN AN ISO CLASS 7 SUITE. THE TECHNICIANS NOTED IT APPEARS THEY MAY BE CRACKED ON THE TOP AND THAT THEY ARE LEAKING WHERE THEY LUER TO THE DEVICE TO FILL IT WITH DRUG/DILUENT. THE DEFECT WAS NOTED WHEN THE TECHNICIAN ATTEMPTED TO ADD GANCICLOVIR (CYTOTOXIC AGENT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7344804 ↗
• MalfunctionMar 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: EVENT 3: THE PUMP IS LEAKING DURING FILLING / IMMEDIATELY AFTER FILLING IN AN ISO CLASS 5 HOOD WITHIN AN ISO CLASS 7 SUITE. THE TECHNICIANS NOTED IT APPEARS THEY MAY BE CRACKED ON THE TOP AND THAT THEY ARE LEAKING WHERE THEY LUER TO THE DEVICE TO FILL IT WITH DRUG/DILUENT. THE DEFECT WAS NOTED WHEN THE TECHNICIAN ATTEMPTED TO ADD GANCICLOVIR (CYTOTOXIC AGENT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7344803 ↗
• MalfunctionMar 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: EVENT 2. THE PUMP IS LEAKING DURING FILLING / IMMEDIATELY AFTER FILLING IN AN ISO CLASS 5 HOOD WITHIN AN ISO CLASS 7 SUITE. THE TECHNICIANS NOTED IT APPEARS THEY MAY BE CRACKED ON THE TOP AND THAT THEY ARE LEAKING WHERE THEY LUER TO THE DEVICE TO FILL IT WITH DRUG/DILUENT. THE DEFECT WAS NOTED WHEN THE TECHNICIAN ATTEMPTED TO ADD GANCICLOVIR (CYTOTOXIC AGENT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7344802 ↗
• MalfunctionMar 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: EVENT 1: THE PUMP IS LEAKING DURING FILLING / IMMEDIATELY AFTER FILLING IN AN ISO CLASS 5 HOOD WITHIN AN ISO CLASS 7 SUITE. THE TECHNICIANS NOTED IT APPEARS THEY MAY BE CRACKED ON THE TOP AND THAT THEY ARE LEAKING WHERE THEY LUER TO THE DEVICE TO FILL IT WITH DRUG/DILUENT. THE DEFECT WAS NOTED WHEN THE TECHNICIAN ATTEMPTED TO ADD GANCICLOVIR (CYTOTOXIC AGENT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7344800 ↗
• MalfunctionMar 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: EVENT 2: THE PUMP IS LEAKING DURING FILLING / IMMEDIATELY AFTER FILLING IN AN ISO CLASS 5 HOOD WITHIN AN ISO CLASS 7 SUITE. THE TECHNICIANS NOTED IT APPEARS THEY MAY BE CRACKED ON THE TOP AND THAT THEY ARE LEAKING WHERE THEY LUER TO THE DEVICE TO FILL IT WITH DRUG/DILUENT. THE DEFECT WAS NOTED WHEN THE TECHNICIAN ATTEMPTED TO ADD GANCICLOVIR (CYTOTOXIC AGENT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7344798 ↗
• MalfunctionMar 1, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 1. PRODUCT LEAKED DURING THE COMPOUNDING OF CYTARABINE. UNITS WERE DISPOSED OF IN ACCORDANCE WITH HAZARDOUS SUBSTANCE PROTOCOLS. COMPOUNDING WAS OCCURRING WITHIN THE BSC AND THE CLINICIAN WAS WEARING THE PROPER PPE. NO SKIN CONTACT, EXPOSURE TO GLOVES/CHEMO GOWN ONLY. EXPOSED PPE WAS REMOVED AND DISPOSED OF IN ACCORDANCE WITH LOCAL HAZARDOUS WASTE DISPOSAL PROTOCOLS. BSC WAS DECONTAMINATED PER COMPANY PROTOCOL. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7307335 ↗
• MalfunctionMar 1, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 2: PRODUCT LEAKED DURING THE COMPOUNDING OF CYTARABINE. UNITS WERE DISPOSED OF IN ACCORDANCE WITH HAZARDOUS SUBSTANCE PROTOCOLS. COMPOUNDING WAS OCCURRING WITHIN THE BSC AND THE CLINICIAN WAS WEARING THE PROPER PPE. NO SKIN CONTACT, EXPOSURE TO GLOVES/CHEMO GOWN ONLY. EXPOSED PPE WAS REMOVED AND DISPOSED OF IN ACCORDANCE WITH LOCAL HAZARDOUS WASTE DISPOSAL PROTOCOLS. BSC WAS DECONTAMINATED PER COMPANY PROTOCOL. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7307315 ↗