BD Alaris PCU Module, Model 8015Recalls & reported problems across all models

We found 2 models of BD Alaris PCU Module, Model 8015 by Carefusion 303, Inc. in the FDA's device registry (GUDID). Together they are named in 3,078 adverse event reports in the FDA's MAUDE database, received between Nov 24, 2023 and Sep 30, 2026 — classified as 4 injuries, 3,073 malfunctions.

The most frequently reported specific device problem is “Break” (668 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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

BD Alaris PCU Module, 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.

1. 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 · Recall details · FDA record ↗

2. 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 ↗

3. Sep 15, 2023Open, Classified

   Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

   Z-0186-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported BD Alaris PCU Module, Model 8015 problems

BD Alaris PCU Module, Model 8015 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BD Alaris™ PCU Module, Model 8015

  Pump, infusion
  2 recalls3,073 reports
• BD Alaris™ PCU Module, Model 8015

  Pump, infusion
  2 recalls5 reports

Recent BD Alaris PCU Module, 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, 2026Device Alarm System

  It was reported that the device had error code 133.6090 biomed already tried replacing the speaker but got same error. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946170 ↗
• MalfunctionSep 30, 2026Charging 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 50945183 ↗
• MalfunctionSep 30, 2026Device Alarm System

  It was reported that the customer needing assistance with an error code. Not able to connect to Alaris software. There was no patient harm.Additional information was received on 11Sep2026 through due diligence follow up attempts. The device had error code 133.6090. Customer biomed rebooted the device and the same error code appeared.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945155 ↗
• MalfunctionSep 30, 2026Failure to Read Input Signal

  It was reported that the device had turns on by itself and starts beeping. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945131 ↗
• MalfunctionSep 30, 2026Circuit Failure

  It was reported that the device had receiving A/C power will not turn on. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944387 ↗
• MalfunctionSep 29, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933772 ↗
• MalfunctionSep 29, 2026Break; Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932729 ↗
• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932719 ↗
• MalfunctionSep 29, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929907 ↗
• MalfunctionSep 29, 2026Device Markings/Labelling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929897 ↗
• MalfunctionSep 29, 2026Circuit Failure

  It was reported that the device had powers on automatically. Flashing red near power button. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929873 ↗
• MalfunctionSep 29, 2026Battery Problem

  It was reported that the device had very low battery message- something wrong with charging. replaced the battery and still didnt work. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929866 ↗
• MalfunctionSep 29, 2026Inadequate or Insufficient Training

  It was reported that the device had error 800.8000. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928402 ↗
• MalfunctionSep 28, 2026Premature Discharge of Battery

  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 50914091 ↗
• MalfunctionSep 28, 2026Electrical /Electronic Property Problem

  It was reported that the device had red light above system on button constantly stayed on and beeping. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913294 ↗

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
• Alaris PCA Module, Model 81202 models · 918 reports · 2 recalls
• BD Alaris ETCO2 Module, Model 83002 models · 956 reports