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Medex FS113Recalls & reported problems

Icu Medical, Inc. · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10351688510983), received between Dec 30, 2021 and Jul 11, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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

Device problems

  • Fluid/Blood Leak3

Patient problems

  • Insufficient Information2
  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionJul 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT THE SET LEAKED IN THE NICU.

    Patient problems: Insufficient Information

    MAUDE report 14982228 ↗
  • MalfunctionJan 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT THERE WAS LEAKING ABOVE THE FILTER. NO ADVERSE EFFECTS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13175997 ↗
  • MalfunctionDec 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT A PATIENT WITH LOW CBS HAD IV FLUIDS NOTED TO BE LEAKING BELOW THE FILTER. THE FILTER SET WAS CHANGED AND NO MORE LEAKING WAS NOTED.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 13122276 ↗

Other Filter, infusion line devices

All Filter, infusion line devices →

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