Blender 10041ARecalls & reported problems
Carefusion Corporation · MICBLNDR,0.5-5.0/2-16 LPM,DISS,CE,LO · Class 2
- 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 10846446002195), received between Mar 8, 2023 and Nov 28, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical 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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem1
- Volume Accuracy 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.
MalfunctionNov 28, 2023Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT FRACTION OF INSPIRED OXYGEN INACCURACY OCCURRED ON THE MICROBLENDER DEVICE. WHEN SET AT 21% AND 100% IT IS READING 25% AND 97%. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18223265 ↗MalfunctionMar 8, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE FIO2 (FRACTION OF INSPIRED OXYGEN) ALARM WAS NOT WORKING WHEN THE BLENDER WAS DISCONNECTED FROM O2 UNTIL SET AT 29%. THERE IS NO INFORMATION OF PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT AS OF THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16504733 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.