FLUID SYSTEMS ACCESSORIES 2N3368Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00085412639444), received between Jun 7, 2021 and May 27, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF AIR ELIMINATING 1.2 MICROMETER SOLUTION FILTERS LEAKED AT THE SLIP CONNECTION TO UNSPECIFIED EXTENSION SETS. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP AT THE NICU DEPARTMENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306006 ↗
• MalfunctionMay 21, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) AIR ELIMINATING 1.2 MICROMETER SOLUTION FILTERS LEAKED FROM THE FEMALE CONNECTION SITE. THE EVENTS OCCURRED DURING INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241787 ↗
• MalfunctionMay 18, 2026Air/Gas in Device

  IT WAS REPORTED THAT AIR WAS OBSERVED IN A AIR ELIMINATING 1.2 MICROMETER SOLUTION FILTER CONNECTED TO A BAXTER EXTENSION SET. THE ISSUE WAS IDENTIFIED WHILE THE REGISTERED NURSE WAS PRIMING THE LINE ON THE INFUSION PUMP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210770 ↗
• MalfunctionMar 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN AIR-ELIMINATING 1.2M SOLUTION FILTER LEAKED. THE LEAK WAS FOUND AT THE CONNECTION BETWEEN THE MEDLINE AND THE AIR FILTER FURTHEST FROM PATIENT END. THE EVENT OCCURRED DURING SMOF LIPID INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16619691 ↗
• MalfunctionJun 7, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) AIR-ELIMINATING 1.2 M SOLUTION FILTERS CRACKED WHICH RESULTED IN FLUID LEAKS. THIS ISSUE WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952041 ↗