EASYPUMP 4540058-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964449239), received between Aug 2, 2017 and Oct 10, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY USER FACILITY: VANCOMYCIN IN NSS INFUSED OVER 6 HOURS WHEN IT WAS SUPPOSED TO INFUSE OVER 24 HOURS. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952830 ↗
• MalfunctionMar 1, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED BY END USER : PUMP WAS TAKING A LONG TIME TO INFUSE SO THE PATIENT CALLED THE NURSE TO CHECK IT AND WHEN THE EASY PUMP WAS DISCONNECTED FROM THE PATIENT'S PORT THERE SEEMED TO BE A HARD PIECE PRESENT. THE PUMP WAS FILLED WITH 900MG/300ML OF RIFAMPIN. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7307311 ↗
• MalfunctionAug 2, 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: Skin Irritation

  MAUDE report 6762256 ↗