NA 2C5685Recalls & reported problems
Baxter International Inc. · Minivolume Extension Set, Male Luer Lock Adapter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00085412003832), received between Feb 6, 2025 and Feb 6, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- Incomplete or Inadequate Connection1
- Pressure Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2025Fluid/Blood Leak; Incomplete or Inadequate Connection; Fluid/Blood Leak; Incomplete or Inadequate Connection
IT WAS REPORTED THAT A MINIVOLUME EXTENSION SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED WHEN THE CARDIOPLEGIA SOLUTION WAS BEING PASSED WITH THE NECESSARY PRESSURE; HOWEVER, THE CARDIOPLEGIA SOLUTION SPILLED DUE TO AN UNSATISFACTORY CLOSURE. 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 21326128 ↗MalfunctionFeb 6, 2025Pressure Problem; Pressure Problem
IT WAS REPORTED THAT A MINIVOLUME EXTENSION SET WAS USED TO MEASURE THE PRESSURE WITH WHICH THE BLOOD SHOULD CIRCULATE; HOWEVER, THE SET "FAILS TO PERCEIVE OR REFLECT THE PRESSURE". THIS WAS OBSERVED DURING PATIENT USE. 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 21324841 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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