BD Alaris PCU Model 8015Recalls & reported problems across all models
Carefusion 303, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one BD Alaris PCU Model 8015 model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4,071
- Deaths reported
- 3
- Injuries reported
- 8
- Recalls
- 2
We found 3 models of BD Alaris PCU Model 8015 by Carefusion 303, Inc. in the FDA's device registry (GUDID). Together they are named in 4,071 adverse event reports in the FDA's MAUDE database, received between Aug 21, 2024 and Sep 30, 2026 — classified as 3 deaths, 8 injuries, 4,059 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (913 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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. 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
BD Alaris PCU Model 8015 recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 11, 2026Open, Classified
Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
Z-1645-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · 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-3138-2024 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported BD Alaris PCU Model 8015 problems
Device problems
- Device Alarm System913
- Break532
- Circuit Failure484
- Premature Discharge of Battery430
- Battery Problem364
- Output Problem279
- Electrical /Electronic Property Problem226
- Corroded139
Patient problems
- No Clinical Signs, Symptoms or Conditions4,024
- Insufficient Information41
- Hyperglycemia2
- Low Blood Pressure/ Hypotension2
- Blister1
- Cardiac Arrest1
- Cramp(s) /Muscle Spasm(s)1
- Decreased Level of Consciousness1
BD Alaris PCU Model 8015 models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD® Alaris™ PCU Model 8015Pump, infusion1 recall3 deaths3,873 reports
- BD® Alaris™ PCU Model 8015Pump, infusion1 recall153 reports
- BD® Alaris™ PCU Model 8015Pump, infusion2 recalls45 reports
Recent BD Alaris PCU Model 8015 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Output Problem
It was reported that the device had tamper switch is damaged and can't enter maintenance mode. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946171 ↗MalfunctionSep 30, 2026Failure to Power Up
It was reported that the device had device will not power on. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945190 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device had 133.6090. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945164 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device had system error on startup. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945160 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device during battery reconditioning, system errored and found 800.8000. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945153 ↗MalfunctionSep 30, 2026Failure to Read Input Signal
It was reported that the device had display is peeling on right bottom side. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945152 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device had system error 110.6021. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945123 ↗MalfunctionSep 30, 2026Battery Problem
It was reported that the device battery is not charging. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945120 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device had system error alarm. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944989 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device had error code 133.6090. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944988 ↗MalfunctionSep 30, 2026Circuit Failure
It was reported that the device wouldn't turn on even though it was plugged in for hours. When unplugged, would turn on randomly after being turned off. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944376 ↗MalfunctionSep 30, 2026Premature Discharge of Battery
It was reported that the device States battery needs to be replaced. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944180 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device had gets system error alarm 133.6080. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942542 ↗MalfunctionSep 30, 2026Battery Problem
It was reported that the device had battery conditioning test, it gets stuck on recharging. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942236 ↗MalfunctionSep 30, 2026Circuit Failure
It was reported that the device washed out screen. There was patient involvement but unknown harm.
Patient problems: Insufficient Information
MAUDE report 50942091 ↗
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 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
- BD Alaris ETCO2 Module, Model 83002 models · 956 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page