Alaris 8100 (UDI 10885403810039)Recalls & reported problems
Carefusion 303, Inc. · Alaris Pump Module · Class 2
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Alaris 8100 infusion pump module delivers fluids to patients. Of its 6,801 reports, 1 describes a death and 9 describe injuries, and most describe malfunctions such as breaks, sensing failures and corrosion. There are 3 open recalls, covering damage from drops or jolts, flow rates outside the expected range, and a bent connector that can delay infusion. Reports dropped from 397 in the prior year to 246 in the latest year.
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
- 6,859
- Deaths reported
- 1
- Injuries reported
- 9
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 6,859 adverse event reports that list this exact device (DI 10885403810039), received between Feb 19, 2020 and Sep 29, 2026 — classified as 1 death, 9 injuries, 6,849 malfunctions.
The most frequently reported specific device problem is “Break” (1,987 reports).
3 FDA recall records name this device's identifier, 3 still open.
5 other recalls cover devices cleared under the same FDA submission (K072105); they may or may not involve this specific model.
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
Recalls naming this device
- Oct 17, 2025Open, Classified
If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.
Z-0430-2026 · Root cause: Device Design · FDA record ↗
- Jul 8, 2025Open, Classified
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Z-2179-2025 · Root cause: Under Investigation by firm · FDA record ↗
- Aug 15, 2024Open, 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-3142-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Break1,987
- Device Sensing Problem1,807
- Corroded1,357
- Display Difficult to Read973
- Crack507
- Application Program Freezes or Fails to Launch340
- Physical Resistance/Sticking327
- Device Alarm System315
Patient problems
- No Clinical Signs, Symptoms or Conditions6,660
- No Patient Involvement190
- Insufficient Information27
- No Consequences Or Impact To Patient7
- No Information2
- Cardiopulmonary Arrest1
- High Blood Pressure/ Hypertension1
- Hypoglycemia1
Recent adverse event reports
The 25 most recent of 6,859 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Display Difficult to Read
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932715 ↗MalfunctionSep 29, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931721 ↗MalfunctionSep 29, 2026Display Difficult to Read
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Failed schedule PM inspection due to dim display segment.No patient involvement - Failure observed during routine preventative maintenance.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931535 ↗MalfunctionSep 24, 2026Break
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Fail schedule PM inspection; cracked door assembly.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881998 ↗MalfunctionSep 24, 2026Display Difficult to Read
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Fail schedule PM inspection; cracked door assembly.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881345 ↗MalfunctionSep 24, 2026Device Sensing Problem; Output Problem
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Fail schedule PM checks: error 242.4030.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881342 ↗MalfunctionSep 24, 2026Break
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]"; "[Fail schedule PM inspection; cracked door assembly.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880558 ↗MalfunctionSep 24, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880557 ↗MalfunctionSep 24, 2026Device Sensing Problem
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Fail schedule PM checks: error 241.4140.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880548 ↗MalfunctionSep 24, 2026Device Sensing Problem
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Fail schedule PM inspection; cracked door assembly.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880031 ↗MalfunctionSep 21, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838492 ↗MalfunctionSep 21, 2026Break
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Fail schedule PM inspection; cracked door assembly.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50835188 ↗MalfunctionSep 21, 2026Device Sensing Problem
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Fail schedule PM inspection; cracked door assembly.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50835156 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823227 ↗MalfunctionSep 18, 2026Break
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Fail schedule PM inspection; cracked door assembly.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817580 ↗MalfunctionSep 18, 2026Break; Device Sensing Problem
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Fail schedule PM inspection; cracked door assembly.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817578 ↗MalfunctionSep 18, 2026Display Difficult to Read
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Fail schedule PM inspection; dimmed segment]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817573 ↗MalfunctionSep 18, 2026Break
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]"; "[Fail schedule PM inspection; cracked door assembly.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816833 ↗MalfunctionSep 18, 2026Break
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]"; "[Fail schedule PM inspection; cracked door assembly.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816832 ↗MalfunctionSep 18, 2026Break; Device Sensing Problem
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Fail schedule PM inspection; cracked door assembly.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816829 ↗MalfunctionSep 18, 2026Break
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Fail schedule PM inspection; cracked door assembly.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816824 ↗MalfunctionSep 18, 2026Break
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Fail schedule PM inspection; cracked door assembly.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816823 ↗MalfunctionSep 18, 2026Break
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Fail schedule PM inspection; cracked door assembly.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816822 ↗MalfunctionSep 18, 2026Break; Device Sensing Problem
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Fail schedule PM inspection; cracked door assembly.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816816 ↗MalfunctionSep 18, 2026Break
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Fail schedule PM inspection; cracked door assembly.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816100 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K072105. One submission often covers many models, so check the product and lot details in each record.
- Z-1645-2026 · Feb 11, 2026 · Open, ClassifiedBD Alaris" System with Guardrails" Suite MX with Point of Care Unit
- Z-0186-2024 · Sep 15, 2023 · Open, ClassifiedAlaris PCA Module 8120
- Z-0185-2024 · Sep 15, 2023 · Open, ClassifiedBD Alaris Syringe Module, REF 8110
- Z-0184-2024 · Sep 15, 2023 · Open, ClassifiedBD Alaris PCU REF 8015
- Z-1192-2023 · Jan 24, 2023 · Open, ClassifiedAlaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
Other Pump, infusion devices
- Alaris 8100Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths650,218 reports
- Alaris 8100Carefusion 303, Inc. · Pump, infusion4 recalls78 deaths344,514 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion2 recalls45 deaths148,093 reports
- BD® Alaris™ Pump Module, Model 8100Carefusion 303, Inc. · Pump, infusion5 recalls30 deaths51,256 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls4 deaths21,956 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths15,547 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion3 recalls6 deaths13,022 reports
- CADD 21-6500-51Icu Medical, Inc. · Pump, infusion2 deaths8,231 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.