BD Alaris™ PCU Module, Model 8015 (REF 8015BDCDXEN1231)Recalls & reported problems
Carefusion 303, Inc. · BD Alaris™ PCU Module, Model 8015 v12.3.1 · Class 2
All models of BD Alaris PCU Module, Model 8015 (2)
Data updated Oct 16, 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 BD Alaris PCU module is part of an infusion pump system. Its 2,980 adverse event reports often describe parts breaking, alarm problems and batteries that drain early. Many recent reports describe failures found during scheduled maintenance, with no patient involvement. The reports include no deaths and 4 injuries. Two open recalls name this device: one over a bent connector that could delay infusion, and one over syringe compatibility labels.
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
- 3,073
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 3,073 adverse event reports that list this exact device (DI 10885403516023), received between Nov 24, 2023 and Sep 30, 2026 — classified as 4 injuries, 3,068 malfunctions.
The most frequently reported specific device problem is “Break” (667 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-3138-2024 · Root cause: Process control · Recall details · 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-0186-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Break667
- Device Alarm System449
- Circuit Failure362
- Premature Discharge of Battery302
- Electrical /Electronic Property Problem255
- Contamination244
- Corroded204
- Battery Problem184
Patient problems
- No Clinical Signs, Symptoms or Conditions3,059
- Insufficient Information13
- Arrhythmia1
- Cardiac Enzyme Elevation1
- Hypoglycemia1
- Hypoventilation1
Recent adverse event reports
The 25 most recent of 3,073 reports, 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 ↗MalfunctionSep 28, 2026Premature Discharge of Battery
It was reported that the device had error code 120.4540 on top of another replace battery alarm. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913137 ↗MalfunctionSep 25, 2026Device Alarm System
It was reported that the device had error code 133.6090 and error code 133.6080. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896550 ↗MalfunctionSep 25, 2026Contamination
It was reported that the device had error codes 121.2072 and 133.6090. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896539 ↗MalfunctionSep 25, 2026Battery Problem
It was reported that the device had battery reconditioning failed multiple times with 2 different batteries. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895433 ↗MalfunctionSep 25, 2026Use of Device Problem
It was reported that the device had System error - 133:6080. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895131 ↗MalfunctionSep 24, 2026Break
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 50881899 ↗MalfunctionSep 24, 2026Electrical /Electronic Property Problem
It was reported that the device had when unit turned on it flashes red and alarms, immediately says system error. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881893 ↗MalfunctionSep 24, 2026Break; Circuit Failure
It was reported that the device had Lights on but no body home. AC, Battery, and system lights on all the time. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880008 ↗MalfunctionSep 23, 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 50870783 ↗MalfunctionSep 23, 2026Battery Problem
It was reported that the device had will not charge. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870549 ↗
Other Pump, infusion devices
- Alaris 8100Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths650,218 reports
- Alaris 8100Carefusion 303, Inc. · Pump, infusion4 recalls78 deaths344,514 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion2 recalls45 deaths148,093 reports
- BD® Alaris™ Pump Module, Model 8100Carefusion 303, Inc. · Pump, infusion5 recalls30 deaths51,256 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls4 deaths21,956 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths15,547 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion3 recalls6 deaths13,022 reports
- CADD 21-6500-51Icu Medical, Inc. · Pump, infusion2 deaths8,231 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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