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EASYPUMP 4540056-02Recalls & reported problems

B. Braun Medical Inc. · Easypump® ST 100-2-S1 · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964449185), received between Apr 6, 2023 and Apr 6, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (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

Device problems

  • Excess Flow or Over-Infusion1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 6, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

    AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE EASYPUMP IS INFUSING TOO QUICKLY (INFUSION COMPLETED 30 MINUTES SOONER THAN EXPECTED). NO INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16688087 ↗

Other PUMP, INFUSION, ELASTOMERIC devices

All PUMP, INFUSION, ELASTOMERIC devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.