BD® Alaris™ PCU Model 8015 (REF 8015BDUDXEN1240)Recalls & reported problems
Carefusion 303, Inc. · BD Alaris™ PCU Model 8015 v12.4.0 · Class 2
All models of BD Alaris PCU Model 8015 (3)
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 8015 is a point-of-care infusion pump used at bedsides. The 45 reports mostly describe the unit alarming constantly or not switching off, failing to read signals, output problems, batteries discharging early, and broken parts or circuit failures. No deaths or injuries are reported. Two open recalls: one from August 2024 over bent connectors that can stop the pump working and delay infusion, and one from February 2026 because the labeling does not say which Wi-Fi security setting hospitals need for secure communication.
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
- 45
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10885403519215), received between Sep 18, 2024 and Aug 30, 2026 — classified as 45 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (12 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
- 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 ↗
- 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 ↗
Most reported problems
Device problems
- Device Alarm System12
- Failure to Read Input Signal6
- Output Problem5
- Premature Discharge of Battery5
- Battery Problem4
- Break4
- Circuit Failure4
- Electrical /Electronic Property Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions45
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 30, 2026Failure to Read Input Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50511719 ↗MalfunctionAug 13, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50231619 ↗MalfunctionAug 7, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50174250 ↗MalfunctionAug 4, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50130390 ↗MalfunctionJul 10, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25779685 ↗MalfunctionJul 9, 2026Device Alarm System; Circuit Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25760390 ↗MalfunctionJul 7, 2026Circuit Failure; Failure to Read Input Signal; Output Problem
IT WAS REPORTED THAT THE DEVICE HAD UNIT CONSTANTLY ALARMS AND WILL NOT TURN OFF. HAD TO PULL BATTERY AND RESET PUMP PER TECH SUPPORT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25729808 ↗MalfunctionJun 24, 2026Device Alarm System
IT WAS REPORTED THAT THE DEVICE HAD 110-6021. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25608395 ↗MalfunctionJun 24, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT THE DEVICE HAD RED ARROW ALARM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25607238 ↗MalfunctionJun 11, 2026Device Alarm System
IT WAS REPORTED THAT THE DEVIC E HAD ERROR CODE 120.449. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25467964 ↗MalfunctionMay 25, 2026Output Problem
IT WAS REPORTED THAT THE DEVICE HAD WON'T ENTER MAINTENANCE MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25268511 ↗MalfunctionMay 8, 2026Device Alarm System
IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE: 133.6090. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25123121 ↗MalfunctionApr 28, 2026Break; Output Problem
IT WAS REPORTED THAT THE DEVICE HAD TAMPER SWITCH NOT WORKING - DOESN'T ALLOW DEVICE TO GO INTO MAINTENANCE MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25011919 ↗MalfunctionApr 3, 2026Failure to Read Input Signal
IT WAS REPORTED THAT THE DEVICE HAD BUTTON ON KEYBOARD STUCK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24775321 ↗MalfunctionFeb 26, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT THE DEVICE HAD 110.6021. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452089 ↗MalfunctionFeb 20, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED FOR THE REPORTED FAILURE AS IT WAS OBSERVED BY THE MANUFACTURER DURING SERVICING ACTIVITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24398480 ↗MalfunctionFeb 12, 2026Device Alarm System
IT WAS REPORTED THAT THE DEVICE HAD 255-202-2 BATTERY RECONDITIONING ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24321643 ↗MalfunctionDec 25, 2025Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE HAD 'SYSTEM ERROR' MESSAGE DURING RECONDITIONING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23892205 ↗MalfunctionDec 22, 2025Inadequate or Insufficient Training; Inadequate or Insufficient Training
IT WAS REPORTED THAT THE DEVICE HAD BATTERY RECONDITIONING ISSUES AND WERE NOT CHARGING EVEN AFTER WAITING OVERNIGHT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23862119 ↗MalfunctionDec 18, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE DEVICE HAD NOT GIVING NUMERICAL DATA AFTER THE BATTERY HAS BEEN RECONDITIONED, STUCK IN DISCHARGE STATUS, REPLACED WITH NEW BATTERY AND SAME CONDITION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23836692 ↗MalfunctionDec 2, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE DEVICE HAD BROKEN TAMPER SWITCH. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23691099 ↗MalfunctionNov 10, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE DEVICE DISPLAYED ERROR CODE 120.4610 DURING AN INFUSION WHILE ATTACHED TO A PATIENT ON (B)(6) 2025 AT 0437. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23507648 ↗MalfunctionNov 7, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE DEVICE HAD WILL NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23495038 ↗MalfunctionNov 5, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PC UNIT IS SHOWING THAT AFTER BEING CHARGED, THE RANGE IS STILL SHOWING AS "LOW", "NOT FULLY CHARGED." THE READINGS WERE AS FOLLOWS: 3886, 3960, 3564, 3960. PER REPORT, THE DEVICE IS LESS THAN A YEAR OLD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23473606 ↗MalfunctionOct 23, 2025Break; Break
IT WAS REPORTED THAT THE DEVICE HAD FAILED PM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23365514 ↗
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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