Alaris™ PCA Module, Model 8120 (REF 8120BDXEN123)Recalls & reported problems
Carefusion 303, Inc. · Alaris™ PCA Module, Model 8120 v12.3.0 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Alaris PCA Module infusion pump appears in 869 adverse event reports, including 1 death and 1 injury. Many describe broken parts, calibration problems and inaccurate delivery, with some mentioning door sensors failing and the module not being recognized by maintenance software. Two open recalls cover bent connectors that may delay the start of infusion or monitoring, and syringe labeling that lists syringes not validated for use.
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
- 917
- Deaths reported
- 1
- Injuries reported
- 2
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 917 adverse event reports that list this exact device (DI 10885403516030), received between Dec 22, 2023 and Sep 30, 2026 — classified as 1 death, 2 injuries, 913 malfunctions.
The most frequently reported specific device problem is “Break” (257 reports).
2 FDA recall records name this device's 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, 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
- 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 · FDA record ↗
- 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 · FDA record ↗
Most reported problems
Device problems
- Break257
- Calibration Problem172
- Device Alarm System103
- Inaccurate Delivery97
- Failure to Read Input Signal68
- Device Sensing Problem63
- No Apparent Adverse Event47
- Electrical /Electronic Property Problem43
Patient problems
- No Clinical Signs, Symptoms or Conditions893
- Insufficient Information25
- Pain2
- Chest Pain1
- Decreased Level of Consciousness1
- Hallucination1
- Loss of consciousness1
Recent adverse event reports
The 25 most recent of 917 reports, 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 ↗InjurySep 22, 2026Fail-Safe Problem
It was initially reported the customer requested a log review for a possible Tampering/Diversion event. Fentanyl PCA was programmed (b)(6)2026 and the PCA door was found unlocked. Additional information received through due diligence attempts on (b)(6)2026: Per report, the customer stated a suspected tampering/diversion event occurred on (b)(6)2026 at approximately 0600 when a clinician caring for the patient was found unconscious in a bathroom and subsequently admitted to withdrawing volume from a fentanyl PCA syringe and self-administering the medication. The clinician had worked from (b)(6)2026 1900 to (b)(6)2026 0700 and returned for a shift from (b)(6)2026 1900 until being discovered the following morning. The customer reported that the suspected tampering occurred shortly after the fentanyl syringe was installed based on a discrepancy between the expected and observed volume to be infused (VTBI) displayed by the PCA module. The fentanyl PCA was programmed as a continuous infusion titratable from 0 to 200 mcg/hr with no bolus doses enabled. Naloxone was administered to the clinician, who was transported to the Emergency Department for further evaluation and treatment.
Patient problems: Loss of consciousness
MAUDE report 50850123 ↗MalfunctionSep 21, 2026Break
It was reported that the device had flange detect failure. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838464 ↗MalfunctionSep 21, 2026Electrical /Electronic Property Problem
It was reported that the device had dose cord press failure. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838434 ↗MalfunctionSep 17, 2026Calibration Problem
It was reported that the device had failed adjusting to starting position. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50800214 ↗MalfunctionSep 17, 2026Break
It was reported that Patient controlled analgesia module had defective seal wiper shaft, barrel wiper shaft and barrel clamp. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797953 ↗MalfunctionSep 16, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787113 ↗MalfunctionSep 16, 2026Break
It was reported that the device had plunger head - damaged/stuck. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50785689 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50785595 ↗MalfunctionSep 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50770839 ↗MalfunctionSep 15, 2026Calibration Problem
It was reported that the device had PCA Switch - Split Nut failure. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50770837 ↗
Other Pump, infusion, pca devices
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- CADD 21-2112-0300-01Icu Medical, Inc. · Pump, infusion, pca1 recall406 reports
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- Nimbus II PainPROInfutronix LLC · Pump, Infusion, Pca2 recalls186 reports
- CADD 21-2111-0402-51LIcu Medical, Inc. · Pump, infusion, pca3 recalls127 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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