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APEX® 601238Recalls & reported problems

B. Braun Medical Inc. · APEX, TPN CONTROL MODULE, WIN-10 · 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 04046955589531), received between Mar 3, 2021 and Mar 3, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Data Problem” (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

  • Data Problem1
  • Labelling, Instructions for Use or Training Problem1

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.

  • MalfunctionMar 3, 2021Labelling, Instructions for Use or Training Problem; Data Problem; Labelling, Instructions for Use or Training Problem; Data Problem

    AS PER REPORTED BY THE USER FACILITY: THE INFUSION RATE ON THE LABEL IS NOT UPDATING APPROPRIATELY AFTER UPDATING THE PATIENT'S WEIGHT. WHEN THE PROVIDER UPDATES THE PATIENT'S WEIGHT BUT DOES NOT CHANGE THE ML/KG INFUSION VOLUME, THE TOTAL INFUSION VOLUME (ML) APPROPRIATELY CHANGES, HOWEVER THE ML/HR INFUSION RATE DOES NOT UPDATE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11404067 ↗

Other System/device, pharmacy compounding devices

All System/device, pharmacy compounding devices →

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