BD® Alaris™ Pump Module, Model 8100Recalls & reported problems
Carefusion 303, Inc. · BD Alaris™ Pump Module, Model 8100 v12.1.2 · Class 2
5 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is a BD Alaris 8100 pump module. Its reports mostly describe sensing failures, breaks, cracks, corrosion and error codes, and many state no patient was involved. There are 49,742 reports, including 33 deaths and 144 injuries. Five recalls are open: hospital network connection problems, damage from drops that can cause over- or under-infusion, flow accuracy, a manual instruction error and bent connectors.
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
- 51,256
- Deaths reported
- 30
- Injuries reported
- 146
- Recalls naming it
- 5
Summary
The FDA's MAUDE database contains 51,256 adverse event reports that list this exact device (DI 10885403810046), received between Aug 9, 2021 and Sep 30, 2026 — classified as 30 deaths, 146 injuries, 51,072 malfunctions.
The most frequently reported specific device problem is “Device Sensing Problem” (11,209 reports).
5 FDA recall records name this device's identifier, 5 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
- Nov 6, 2025Open, Classified
Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network
Z-1217-2026 · Root cause: Under Investigation by firm · FDA record ↗
- Oct 17, 2025Open, Classified
If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.
Z-0430-2026 · Root cause: Device Design · FDA record ↗
- Jul 8, 2025Open, Classified
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Z-2179-2025 · Root cause: Under Investigation by firm · FDA record ↗
- Jan 23, 2025Open, Classified
Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open.
Z-1231-2025 · Root cause: Under Investigation by firm · 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-3142-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Device Sensing Problem11,209
- Break8,910
- Display Difficult to Read7,815
- Corroded7,077
- Failure to Sense6,214
- Device Alarm System6,137
- Crack5,742
- Contamination4,853
Patient problems
- No Clinical Signs, Symptoms or Conditions50,588
- Insufficient Information656
- Low Blood Pressure/ Hypotension61
- High Blood Pressure/ Hypertension18
- Hyperglycemia13
- Hypoglycemia12
- Bradycardia8
- Tachycardia7
Recent adverse event reports
The 25 most recent of 51,256 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device Sensing Problem
It was reported that the device had failed patient side occlusion. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950578 ↗MalfunctionSep 30, 2026Contamination; Corroded; Use of Device Problem
It was reported an over infusion of Magnesium. On (b)(6)2026 at 0925 Magnesium Sulfate 50ml was to infuse at a rate of 33.3ml/hr; however, at approximately 1045 the "entire bag was found to be empty". This was a one-time order for Magnesium replacement. No other medications were infusing at the time of the event. The Magnesium was programmed manually using guardrails library. This did not occur at shift change. There was patient involvement and no harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947222 ↗MalfunctionSep 30, 2026Device Sensing 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 50946196 ↗MalfunctionSep 30, 2026Device Sensing 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 50946192 ↗MalfunctionSep 30, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946191 ↗MalfunctionSep 30, 2026Failure to Sense
It was reported that the device had error code 242.4030. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946180 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device had error code 242.4030. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946152 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device displayed multiple error codes 241.4140, 242.4010 and 242.4030. Device needs new right IUI. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946150 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device had error code 242.4030. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945874 ↗MalfunctionSep 30, 2026Failure to Sense
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 50945187 ↗MalfunctionSep 30, 2026Device Sensing 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 50945186 ↗MalfunctionSep 30, 2026Device Sensing Problem
It was reported that the device had Will not turn on. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945184 ↗MalfunctionSep 30, 2026Device Sensing 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 50945179 ↗MalfunctionSep 30, 2026Device Sensing 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 50945178 ↗MalfunctionSep 30, 2026Failure to Sense
It was reported that the device displayed channel error code 242.4030. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945166 ↗MalfunctionSep 30, 2026Failure to Sense
It was reported that the device had error code 242.4030. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945163 ↗MalfunctionSep 30, 2026Break
It was reported that the device had air in line issue. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945151 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device had channel error 242.4030. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945150 ↗MalfunctionSep 30, 2026Crack
It was reported that the device had error message safety clamp open even when closed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945148 ↗MalfunctionSep 30, 2026Circuit Failure
It was reported that the device had Unit will not power on either side of the PCU. May be due to IUI issue. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945147 ↗MalfunctionSep 30, 2026Break
It was reported that the device had broken door latch. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945146 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device displayed channel error 242.4030. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945145 ↗MalfunctionSep 30, 2026Device Alarm System
It was reported that the device displayed channel error code 242.4030, when door was opened. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945143 ↗MalfunctionSep 30, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945142 ↗MalfunctionSep 30, 2026Calibration Problem
It was reported that the device had failed pressure transducer testing and rate calibration testing. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945141 ↗
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
- 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
- CADD 21-6400-51Icu Medical, Inc. · Pump, infusion7 deaths7,543 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.