Alaris PCA Module, Model 8120Recalls & reported problems across all models

We found 2 models of Alaris PCA Module, Model 8120 by Carefusion 303, Inc. in the FDA's device registry (GUDID). Together they are named in 918 adverse event reports in the FDA's MAUDE database, received between Dec 22, 2023 and Sep 30, 2026 — classified as 1 death, 2 injuries, 914 malfunctions.

The most frequently reported specific device problem is “Break” (257 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

Alaris PCA Module, Model 8120 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. 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-3139-2024 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

2. Sep 15, 2023Open, Classified

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

   Z-0184-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Alaris PCA Module, Model 8120 problems

Alaris PCA Module, Model 8120 models

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

• Alaris™ PCA Module, Model 8120

  Pump, infusion, pca
  2 recalls1 death917 reports
• Alaris™ PCA Module, Model 8120

  Pump, infusion
  1 recall1 report

Recent Alaris PCA Module, Model 8120 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  It was reported that the device had missing claws. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945191 ↗
• MalfunctionSep 30, 2026Excess Flow or Over-Infusion

  It was reported the PCA continued to infuse following an alarm being triggered. The device continued to infuse at the programmed dose and rate. There was patient involvement; however, outcome is unknown.

  Patient problems: Insufficient Information

  MAUDE report 50943542 ↗
• MalfunctionSep 30, 2026Naturally Worn

  It was reported that the device had broken wiper assembly. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943537 ↗
• MalfunctionSep 29, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935968 ↗
• MalfunctionSep 29, 2026Circuit Failure

  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 50932694 ↗
• MalfunctionSep 28, 2026Inadequate or Insufficient Training

  It was reported that the 8120 Error 358.2000. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913809 ↗
• MalfunctionSep 25, 2026Inaccurate Delivery

  It was reported that the Patient Controlled Analgesia Pump Module was allegedly displaying a Volume to be Infused of 33mL or other varying volumes rather than the expected 30mL on a Hydromorphone infusion. However, when the customer attempted to recreate the scenario, they were unable to reproduce the issue. There was patient involvement, but no harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894665 ↗
• MalfunctionSep 24, 2026Break; Deformation Due to Compressive Stress

  It was reported that the device had plunger claw is broken. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883633 ↗
• MalfunctionSep 24, 2026Device Alarm System

  It was reported that the device had error code 358.2000. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881314 ↗
• MalfunctionSep 24, 2026Break

  It was reported that the device had unit is unable to be attached to a PCU. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881311 ↗
• MalfunctionSep 24, 2026Device Alarm System

  It was reported that the device had error code 356.6710. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880522 ↗
• MalfunctionSep 24, 2026Break

  It was reported that the device plunger sensor only reads closed and not open also the flange sensor seems to work every other turn. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880514 ↗
• MalfunctionSep 24, 2026Calibration Problem

  It was reported that the device had failed binary switches. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50879992 ↗
• MalfunctionSep 24, 2026Break

  It was reported that the PCA Pump was in a vandalism situation and it appeared there was an object inside the locking mechanism.Customer provided additional information indicating:Only the locking key got damaged , and the individual could not access the drug. The hospital Biomed later accessed the drug syringe while the Director of Pharmacy observed them open the plastic cover. forcing the plastic lever to open. There was no patient Impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877442 ↗
• MalfunctionSep 23, 2026Break

  It was reported that the device had failed binary switches. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868105 ↗

Other Carefusion 303, Inc. products

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• BD Alaris Syringe Module, Model 81102 models · 3,183 reports · 2 recalls
• BD Alaris PCU Module, Model 80152 models · 3,078 reports · 3 recalls
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