BD® Alaris™ PCU Model 8015 (REF 8015BDDDXEN1232)Recalls & reported problems
Carefusion 303, Inc. · BD Alaris™ PCU Model 8015 v12.3.2 · 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 for delivering fluids into patients. Many reports describe alarm faults, parts breaking, and batteries that drain early. The 3,608 reports include 4 deaths and 8 injuries. There is 1 open recall, started in August 2024, over a bent connector that may delay the start of infusion or monitoring. Reports rose to 2,194 in the last 12 months from 1,378 in the previous 12 months.
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
- 3,873
- Deaths reported
- 3
- Injuries reported
- 8
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3,873 adverse event reports that list this exact device (DI 10885403519284), received between Aug 21, 2024 and Sep 30, 2026 — classified as 3 deaths, 8 injuries, 3,861 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (874 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
- 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 System874
- Break504
- Circuit Failure462
- Premature Discharge of Battery423
- Battery Problem333
- Output Problem263
- Electrical /Electronic Property Problem217
- Corroded138
Patient problems
- No Clinical Signs, Symptoms or Conditions3,827
- Insufficient Information40
- Hyperglycemia2
- Low Blood Pressure/ Hypotension2
- Blister1
- Cardiac Arrest1
- Cramp(s) /Muscle Spasm(s)1
- Decreased Level of Consciousness1
Recent adverse event reports
The 25 most recent of 3,873 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Output Problem
It was reported that the device had tamper switch is damaged and can't enter maintenance mode. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946171 ↗MalfunctionSep 30, 2026Failure to Power Up
It was reported that the device had device will not power on. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945190 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device had 133.6090. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945164 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device had system error on startup. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945160 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device during battery reconditioning, system errored and found 800.8000. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945153 ↗MalfunctionSep 30, 2026Failure to Read Input Signal
It was reported that the device had display is peeling on right bottom side. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945152 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device had system error 110.6021. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945123 ↗MalfunctionSep 30, 2026Battery Problem
It was reported that the device battery is not charging. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945120 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device had system error alarm. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944989 ↗MalfunctionSep 30, 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 50944988 ↗MalfunctionSep 30, 2026Circuit Failure
It was reported that the device wouldn't turn on even though it was plugged in for hours. When unplugged, would turn on randomly after being turned off. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944376 ↗MalfunctionSep 30, 2026Premature Discharge of Battery
It was reported that the device States battery needs to be replaced. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944180 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device had gets system error alarm 133.6080. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942542 ↗MalfunctionSep 30, 2026Battery Problem
It was reported that the device had battery conditioning test, it gets stuck on recharging. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942236 ↗MalfunctionSep 30, 2026Contamination
It was reported that the device had not turning on, replaced battery, same issue. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942087 ↗MalfunctionSep 30, 2026Circuit Failure; Physical Resistance/Sticking
It was reported that the device had pump will not power on. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942084 ↗MalfunctionSep 29, 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 50935972 ↗MalfunctionSep 29, 2026Battery Problem
It was reported that the battery needs replaced. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935967 ↗MalfunctionSep 29, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933771 ↗MalfunctionSep 29, 2026Premature Discharge of Battery; Corroded; Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933251 ↗MalfunctionSep 29, 2026Electromagnetic Interference
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933137 ↗MalfunctionSep 29, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932718 ↗MalfunctionSep 29, 2026Contamination; Corroded; Failure to Read Input Signal
It was reported that the device had won't turn on. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932717 ↗MalfunctionSep 29, 2026Electromagnetic Interference
It was reported that the device had Startup files are missing. Please install application. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932705 ↗MalfunctionSep 29, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932675 ↗
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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