BD Alaris ETCO2 Module, Model 8300Recalls & reported problems across all models
Carefusion 303, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 956
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of BD Alaris ETCO2 Module, Model 8300 by Carefusion 303, Inc. in the FDA's device registry (GUDID). Together they are named in 956 adverse event reports in the FDA's MAUDE database, received between Jun 20, 2024 and Sep 30, 2026 — classified as 956 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (425 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BD Alaris ETCO2 Module, Model 8300 problems
Device problems
- Communication or Transmission Problem425
- Calibration Problem234
- Crack157
- Device Alarm System155
- Failure to Calibrate127
- Corroded75
- Break69
- No Device Output63
Patient problems
- No Clinical Signs, Symptoms or Conditions953
- Insufficient Information3
BD Alaris ETCO2 Module, Model 8300 models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Alaris™ ETCO2 Module, Model 8300ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE485 reports
- BD Alaris™ ETCO2 Module, Model 8300ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE471 reports
Recent BD Alaris ETCO2 Module, Model 8300 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Calibrate
It was reported that the device had will not calibrate. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942112 ↗MalfunctionSep 29, 2026Failure to Calibrate
It was reported that the device had failed accuracy test and unable to calibrate. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932676 ↗MalfunctionSep 29, 2026Communication or Transmission Problem
It was reported that the device does not have tubing loaded error message when tubing is loaded. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931442 ↗MalfunctionSep 29, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929892 ↗MalfunctionSep 29, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929890 ↗MalfunctionSep 29, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929868 ↗MalfunctionSep 25, 2026Device Alarm System
It was reported by customer their ETCO2 Module is failing. There was an Oridion Board- Failed- Bit Test error (error code 570.6200) and Oridion Board- Comm Failure error (error code 570.6500) on different dates. There was no patient involvement, as these codes were noted when the device was pulled from the floor and logs downloaded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896554 ↗MalfunctionSep 25, 2026Device Alarm System
It was reported by customer their ETCO2 Module is failing. There was an Oridion Board- Failed- Bit Test error (error code 570.6200) and Oridion Board- Comm Failure error (error code 570.6500) on different dates. There was no patient involvement, as these codes were noted when the device was pulled from the floor and logs downloaded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896552 ↗MalfunctionSep 25, 2026Device Alarm System
It was reported by customer their ETCO2 Module is failing. There was an Oridion Board- Failed- Bit Test error (error code 570.6200) and Oridion Board- Comm Failure error (error code 570.6500) on different dates. There was no patient involvement, as these codes were noted when the device was pulled from the floor and logs downloaded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896551 ↗MalfunctionSep 25, 2026Device Alarm System
It was reported by customer their ETCO2 Module is failing. There was an Oridion Board- Failed- Bit Test error (error code 570.6200) and Oridion Board- Comm Failure error (error code 570.6500). There was no patient involvement, as these codes were noted when the device was pulled from the floor and logs downloaded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895435 ↗MalfunctionSep 25, 2026Communication or Transmission Problem
It was reported that the device had errors 570.6200, 571.6210, 570.6500 in log. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895429 ↗MalfunctionSep 25, 2026Device Alarm System
It was reported by customer their ETCO2 Module is failing. There was an Oridion Board- Failed- Bit Test error (error code 570.6200) and Oridion Board- Comm Failure error (error code 570.6500). There was no patient involvement, as these codes were noted when the device was pulled from the floor and logs downloaded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895426 ↗MalfunctionSep 25, 2026Communication or Transmission Problem
It was reported that the device had disposable not connected error. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895127 ↗MalfunctionSep 25, 2026Device Alarm System
It was reported that the device had error code 570.6200. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895101 ↗MalfunctionSep 25, 2026Device Alarm System
It was reported by customer their ETCO2 Module is failing. There was an Oridion Board- Failed- Bit Test error (error code 570.6200) and Oridion Board- Comm Failure error (error code 570.6500). There was no patient involvement, as these codes were noted when the device was pulled from the floor and logs downloaded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893195 ↗
Other Carefusion 303, Inc. products
- BD Alaris Infusion System29 models · 1,242,913 reports · 16 recalls
- Alaris25 models · 1,236,345 reports · 16 recalls
- BD Pyxis26 models · 81,193 reports · 66 recalls
- Pyxis5 models · 7,862 reports · 16 recalls
- BD Alaris PCU Model 80153 models · 4,071 reports · 2 recalls
- BD Alaris Syringe Module, Model 81102 models · 3,183 reports · 2 recalls
- BD Alaris PCU Module, Model 80152 models · 3,078 reports · 3 recalls
- Alaris PCA Module, Model 81202 models · 918 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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