BD® Alaris™ PCU Model 8015 (REF 8015BDDDXEN1250)Recalls & reported problems
Carefusion 303, Inc. · BD Alaris™ PCU Model 8015 v12.5.0 · Class 2
All models of BD Alaris PCU Model 8015 (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD Alaris PCU infusion pump is a hospital pump used to deliver fluids and medicines. Its 142 reports often describe batteries, alarms, cracked parts and circuit failures, such as the pump powering off or showing error messages, and none describe patient involvement. There are no deaths and no injuries. 1 recall, still open, began in February 2026 over labeling that does not say which network security version to enable for secure Wi-Fi. Reports rose to 130 in the last 12 months from 12 before.
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
- 153
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 10885403519291), received between Aug 5, 2025 and Sep 30, 2026 — classified as 153 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (27 reports).
1 FDA recall record name this device's identifier, 1 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
- 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 ↗
Most reported problems
Device problems
- Battery Problem27
- Device Alarm System27
- Break24
- Circuit Failure18
- Device Markings/Labelling Problem15
- Loose or Intermittent Connection14
- Output Problem11
- Display or Visual Feedback Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions152
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 153 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionSep 29, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932714 ↗MalfunctionSep 29, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930721 ↗MalfunctionSep 24, 2026Device Alarm System; Output Problem
It was reported that the device had error code 132.3000, settings unrestorable. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50879997 ↗MalfunctionSep 21, 2026Device Alarm System
It was reported that the device had error code 255-16-275. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839579 ↗MalfunctionSep 11, 2026Battery Problem
It was reported that the device power supply was not charging. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734685 ↗MalfunctionSep 11, 2026Circuit Failure
It was reported that the device had error code 133.6080. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50728546 ↗MalfunctionSep 9, 2026Inaccurate Delivery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696501 ↗MalfunctionSep 8, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50670387 ↗MalfunctionSep 8, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50664011 ↗MalfunctionSep 2, 2026Circuit Failure; Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569741 ↗MalfunctionSep 2, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569328 ↗MalfunctionAug 31, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518162 ↗MalfunctionAug 31, 2026False Alarm
It was reported that the device had power off and keeps alarming and no response to pushing button. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50516291 ↗MalfunctionAug 30, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50511319 ↗MalfunctionAug 21, 2026Output Problem
It was reported that the device had tamper switch intermittently doesn't work, failed during PM. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50367344 ↗MalfunctionAug 17, 2026Device Alarm System
It was reported that the device had PCU saying start up files were missing, please install application. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50268763 ↗MalfunctionAug 6, 2026Physical Resistance/Sticking
It was reported that the device had keypad failure error message, red screen. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50154067 ↗MalfunctionJul 30, 2026Missing Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50081943 ↗MalfunctionJul 29, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50072960 ↗MalfunctionJul 28, 2026Battery Problem
It was reported that the device had tried with new cable and battery. still, it will not power on or charge. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50052040 ↗MalfunctionJul 27, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50035883 ↗MalfunctionJul 27, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50034773 ↗MalfunctionJul 27, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50033479 ↗MalfunctionJul 27, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50033455 ↗
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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