Alaris 8100 (UDI 10885403810015)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

Most of the 344,325 reports for this Alaris pump module come from service and maintenance checks rather than patient events, describing corrosion, hard-to-read displays and broken or cracked parts. Reports include 654 injuries and 78 deaths. The device is named in 4 recall records, 3 still open, covering damage after drops, flow accuracy and connector problems. Reports fell from 4,250 to 2,306 over the past 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: 344,514
Deaths reported: 78
Injuries reported: 658
Recalls naming it: 4

Summary

The FDA's MAUDE database contains 344,514 adverse event reports that list this exact device (DI 10885403810015), received between Apr 25, 2018 and Sep 30, 2026 — classified as 78 deaths, 658 injuries, 343,778 malfunctions.

The most frequently reported specific device problem is “Corroded” (110,807 reports).

4 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

Last 36 months. The most recent month may be incomplete.

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 ↗
Nov 17, 2017Terminated
The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
Z-0322-2018 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Device problems

Corroded110,807
Display Difficult to Read79,293
Break66,551
Crack41,903
Device Sensing Problem37,272
Contamination13,138
Display or Visual Feedback Problem12,514
Failure to Calibrate10,413

Patient problems

No Clinical Signs, Symptoms or Conditions306,392
No Patient Involvement37,308
No Consequences Or Impact To Patient1,325
Insufficient Information862
No Information847
Low Blood Pressure/ Hypotension236
No Known Impact Or Consequence To Patient94
High Blood Pressure/ Hypertension51

Recent adverse event reports

The 25 most recent of 344,514 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026Device Sensing Problem
It was reported that the following issue was observed on the device: "CRACK IN HINGE & CHANNEL ERROR." Reported Problem Cause Description: "None." Hence, the work Performed in the device includes: "UNIT CHECKED AND FOUND ERROR 240.4150 & CRACK IN HINGE. NEED TO REPLACE PRESSURE SENSOR & DOOR ASSY." There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943561 ↗
MalfunctionSep 30, 2026Device Sensing Problem
It was reported that the following issue was observed on the device: ". CRACK IN HINGE & CHANNEL ERROR" Reported Problem Cause Description: "NONE." Hence, the work Performed in the device includes: "UNIT CHECKED AND FOUND ERROR 240.4150 & CRACK IN HINGE. NEED TO REPLACE PRESSURE SENSOR & DOOR ASSY." There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943560 ↗
MalfunctionSep 30, 2026Device Sensing Problem
It was reported that the following issue was observed on the device: "CHANNEL ERROR AND BROKEN LVP KEYPAD ASSY." Reported Problem Cause Description: "HARDWARE FAILURE." Hence, the work Performed in the device includes: "Found defective Pressure sensor and LVP keypad assembly and replaced it." There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943554 ↗
MalfunctionSep 30, 2026Electrical /Electronic Property Problem
It was reported that the following issue was observed on the device: "BROKEN LVP KEYPAD ASSY." Reported Problem Cause Description: "HARDWARE FAILURE." Hence, the work Performed in the device includes: "Found defective LVP keypad assembly and replaced it." There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943544 ↗
MalfunctionSep 30, 2026Device Sensing Problem
It was reported that the following issue was observed on the device: "CHANNEL ERROR.". Reported Problem Cause Description: "FAULTY PRESSURE SENSOR." Hence, the work Performed in the device includes: "UNIT CHECKED AND FOUND ERROR 241.4150. REPLACED PRESSURE SENSOR." There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943543 ↗
MalfunctionSep 30, 2026Contamination
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Depot Repair]";"[The door is broken.]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942242 ↗
MalfunctionSep 30, 2026Calibration Problem
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Door ajar-safety clamp test failed]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942089 ↗
MalfunctionSep 29, 2026Device Sensing Problem
It was reported that the following issue was observed on the device: "AIR IN LINE ALARM." Reported Problem Cause Description: "None Provided." Hence, the work Performed in the device includes: "NEED TO REPLACE AIR IN LINE." There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932716 ↗
MalfunctionSep 29, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932712 ↗
MalfunctionSep 29, 2026Break; Contamination; Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932690 ↗
MalfunctionSep 29, 2026Break; Corroded; Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931587 ↗
MalfunctionSep 29, 2026Corroded; Device Sensing Problem
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Depot Repair]"; "[Cracked door hinge]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931547 ↗
MalfunctionSep 29, 2026Break; Contamination; Corroded
It was reported that a failure was observed during a planned preventive maintenance or recall remediation service event. There was no patient involvement associated for the reported failure as it was observed by the manufacturer during servicing activity.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931435 ↗
MalfunctionSep 29, 2026Device Sensing Problem
It was reported that the following issue was observed on the device: "CHECK IV SET ALARM." Reported Problem Cause Description: "FAULTY PRESSURE SENSORS." Hence, the work Performed in the device includes: "REPLACED BOTH PRESSURE SENSORS. UNIT CHECKED & FOUND WORKING OK." There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930876 ↗
MalfunctionSep 29, 2026Device Alarm System
It was reported that the following issue was observed on the device: "CHANNEL ERROR". Reported Problem Cause Description: "FAULTY BEZEL ASSY". Hence, the work Performed in the device includes: "REPLACED BEZEL ASSY. UNIT NOW WORKING OK". There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930043 ↗
MalfunctionSep 29, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930042 ↗
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929916 ↗
MalfunctionSep 29, 2026Device Sensing Problem
It was reported that the following issue was observed on the device: "AIR IN LINE ALARM." Reported Problem Cause Description: "REPLACED AIR IN LINE SENSOR. UNIT CHECKED & FNOW WORKING OK." Hence, the work Performed in the device includes: "FAULTY AIR IN LINE SENSOR." There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929914 ↗
MalfunctionSep 29, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929909 ↗
MalfunctionSep 29, 2026Device Sensing Problem
It was reported that the following issue was observed on the device: "CHANNEL ERROR." Reported Problem Cause Description: "FAULTY PRESSURE SENSOR." Hence, the work Performed in the device includes: "UNIT CHECKED AND FOUND ERROR 240.4150. REPLACED PRESSURE SENSOR." There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929908 ↗
MalfunctionSep 29, 2026Device Sensing Problem
It was reported that the following issue was observed on the device: "CHANNEL ERROR." Reported Problem Cause Description: "FAULTY PRESSURE SENSOR." Hence, the work Performed in the device includes: "UNIT CHECKED AND FOUND ERROR 240.4150. REPLACED PRESSURE SENSOR." There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929324 ↗
MalfunctionSep 29, 2026Break; Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929322 ↗
MalfunctionSep 28, 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]"; "[Two pressure sensors failed (patient and bottle)]". There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914064 ↗
MalfunctionSep 28, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914062 ↗
MalfunctionSep 28, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914060 ↗

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, Classified
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Z-0184-2024 · Sep 15, 2023 · Open, Classified
BD Alaris PCU REF 8015
Z-0185-2024 · Sep 15, 2023 · Open, Classified
BD Alaris Syringe Module, REF 8110
Z-0186-2024 · Sep 15, 2023 · Open, Classified
Alaris PCA Module 8120
Z-1192-2023 · Jan 24, 2023 · Open, Classified
Alaris 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

Device details

UDI-DI	`10885403810015`
Brand	Alaris
Model	8100
Company	Carefusion 303, Inc.
Product code	FRN · Pump, infusion
Class	Class 2
FDA submission	K072105
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	Not in Commercial Distribution
Record updated	May 9, 2024

Device type (GMDN): Bedside infusion pump, single-channel

An electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation.

Other Pump, infusion devices

Alaris 8100
Carefusion 303, Inc. · Pump, infusion
2 recalls2 deaths650,218 reports
Alaris 8015
Carefusion 303, Inc. · Pump, infusion
2 recalls45 deaths148,093 reports
BD® Alaris™ Pump Module, Model 8100
Carefusion 303, Inc. · Pump, infusion
5 recalls30 deaths51,256 reports
Alaris 8110
Carefusion 303, Inc. · Pump, infusion
2 recalls4 deaths21,956 reports
Alaris 8110
Carefusion 303, Inc. · Pump, infusion
2 recalls2 deaths15,547 reports
Alaris 8015
Carefusion 303, Inc. · Pump, infusion
3 recalls6 deaths13,022 reports
CADD 21-6500-51
Icu Medical, Inc. · Pump, infusion
2 deaths8,231 reports
CADD 21-6400-51
Icu Medical, Inc. · Pump, infusion
7 deaths7,543 reports

All Pump, infusion devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.