Alaris 8300 (UDI 10885403830020)Recalls & reported problems
Carefusion 303, Inc. · Alaris EtCO2 Module · Class 2
All models of BD Alaris Infusion System (29) · Alaris (25)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This CareFusion Alaris carbon dioxide module is a gas analyzer. Of the 607 reports naming it, most describe communication failures, breaks, cracks and failed calibration tests, with no patient involvement, no injuries and no deaths. Reports fell from 156 in the previous 12 months to 20 in the latest 12 months. One recall, open since August 2024, concerns a bent connector that may stop the device working and delay the start of infusion or monitoring.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 607
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 607 adverse event reports that list this exact device (DI 10885403830020), received between Jun 29, 2021 and May 15, 2026 — classified as 607 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (298 reports).
1 FDA recall record name this device's identifier, 1 still open.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Aug 15, 2024Class IIOpen, Classified
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
Z-3140-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Communication or Transmission Problem298
- Break185
- Crack164
- Failure to Calibrate78
- Loose or Intermittent Connection71
- Device Alarm System55
- Corroded46
- Computer Software Problem45
Patient problems
- No Clinical Signs, Symptoms or Conditions607
Recent adverse event reports
The 25 most recent of 607 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2026Device Alarm System
IT WAS REPORTED THAT THE DEVICE HAD 571.6240.1. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25179904 ↗MalfunctionApr 17, 2026Failure to Calibrate
IT WAS REPORTED THAT THE DEVICE HAD FAILS CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913290 ↗MalfunctionApr 17, 2026Failure to Calibrate
IT WAS REPORTED THAT THE DEVICE HAD FAILS CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911017 ↗MalfunctionApr 16, 2026Inadequate or Insufficient Training
IT WAS REPORTED THAT THE DEVICE HAD ERROR 570.6500. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24895318 ↗MalfunctionApr 15, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE DEVICE HAD 570.6200 ERROR CODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24884363 ↗MalfunctionApr 13, 2026Failure to Calibrate; Calibration Problem
IT WAS REPORTED THAT THE DEVICE HAD FAILED ACCURACY AND CALIBRATION TESTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24860021 ↗MalfunctionApr 13, 2026Failure to Calibrate; Calibration Problem
IT WAS REPORTED THAT THE DEVICE HAD FAILED ACCURACY AND CALIBRATION TESTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24859261 ↗MalfunctionApr 13, 2026Failure to Calibrate; Calibration Problem
IT WAS REPORTED THAT THE DEVICE HAD FAILED ACCURACY AND CALIBRATION TESTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24859240 ↗MalfunctionApr 13, 2026Failure to Calibrate; Calibration Problem
IT WAS REPORTED THAT THE DEVICE HAD FAILED ACCURACY AND CALIBRATION TESTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24859201 ↗MalfunctionApr 13, 2026Failure to Calibrate; Calibration Problem
IT WAS REPORTED THAT THE DEVICE HAD FAILED ACCURACY AND CALIBRATION TESTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24858355 ↗MalfunctionApr 9, 2026Inadequate or Insufficient Training
IT WAS REPORTED THAT THE 8300 HAD ERROR 571.6241. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24824835 ↗MalfunctionMar 6, 2026Inadequate or Insufficient Training
IT WAS REPORTED PART NUMBER 8300 IS NOT DETECTING ON THE 8015. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24528318 ↗MalfunctionMar 3, 2026Inadequate or Insufficient Training
IT WAS REPORTED THAT THE DEVICE HAD ERROR 571.6210 AND ALSO FAILS CO2 CALIBRATION TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24493048 ↗MalfunctionFeb 18, 2026Device Alarm System; Break; Communication or Transmission Problem
IT WAS REPORTED THAT THE DEVICE HAD WILL NOT TURN ON WHEN GAS CONNECTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24375458 ↗MalfunctionFeb 16, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE DEVICE HAD MOTOR WILL NOT TURN ON WHEN CONNECTED TO DISPOSABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343327 ↗MalfunctionDec 25, 2025Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE HAD CHANNEL ERROR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23892214 ↗MalfunctionNov 29, 2025Break; Break
IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23675665 ↗MalfunctionNov 19, 2025Inadequate or Insufficient Training; Inadequate or Insufficient Training
IT WAS REPORTED THAT THE 8300 WAS NOT DETECTING THE LUER INSTALLED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23592820 ↗MalfunctionNov 17, 2025Inadequate or Insufficient Training; Inadequate or Insufficient Training
IT WAS REPORTED THAT THE 8300 HAD ERROR 571.6241. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23566495 ↗MalfunctionNov 13, 2025Inadequate or Insufficient Training; Inadequate or Insufficient Training
IT WAS REPORTED THAT THE 8300 HAD ERROR CODE 570.6500. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23540444 ↗MalfunctionOct 29, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE DEVICE HAD NOT PASSING PM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23412617 ↗MalfunctionOct 9, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE DEVICE HAD WHEN POWERED UP IT NOT GOING INTO THE CORRECT MODE. PER REPORT, THE DEVICE DID NOT DISPLAY THE CHANNEL ID AT POWER UP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23259637 ↗MalfunctionOct 6, 2025Break; Break
IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23219179 ↗MalfunctionSep 18, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE REMEDIATED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23081119 ↗MalfunctionSep 12, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23037214 ↗
Other ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE devices
- Alaris 8300Carefusion 303, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall2 deaths8,444 reports
- BD Alaris™ ETCO2 Module, Model 8300Carefusion 303, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE485 reports
- BD Alaris™ ETCO2 Module, Model 8300Carefusion 303, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE471 reports
- NA GF-210RNihon Kohden Corporation · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE386 reports
- Trilogy IT2110X21BRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls30 reports
- Trilogy Trilogy Evo Ventilator, GermanyRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls26 reports
- Trilogy Evo Trilogy Evo Ventilator with oxygen blending model, GermanyRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls9 reports
- Trilogy Evo EU2100X19Respironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls0 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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