SIGMA Spectrum Infusion Pump 35700BAX2Recalls & reported problems
Baxter Healthcare Corporation · The SIGMA Spectrum Infusion Pump with Master Drug Library is an infusion pump that provides delivery of fluids into a patient in a controlled manner. The pumping mechanism is of linear peristaltic design and uses inlet and outlet valves for flow control. The Spectrum infusion pump is specifically manufactured and calibrated for use with Baxter administration sets. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
8 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Baxter SIGMA Spectrum infusion pump has 11,554 adverse event reports, including 12 deaths and 44 injuries. Many describe false alarms, safety features that fail to work, and failures to sense. There are 9 recalls in total, 8 of them open, covering grease that may wear the mechanism early, software versions, false occlusion alarms, and possible under-delivery of medication without an alarm.
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
- 11,585
- Deaths reported
- 12
- Injuries reported
- 44
- Recalls naming it
- 9
Summary
The FDA's MAUDE database contains 11,585 adverse event reports that list this exact device (DI 00085412498683), received between Dec 27, 2017 and Sep 30, 2026 — classified as 12 deaths, 44 injuries, 11,529 malfunctions.
The most frequently reported specific device problem is “Protective Measures Problem” (3,080 reports).
9 FDA recall records name this device's identifier, 8 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 18, 2026.
Reports received per month
Recalls naming this device
- Nov 28, 2025Class IIOpen, Classified
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
Z-1121-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Jun 20, 2025Class IOpen, Classified
Certain Spectrum infusion pumps may have an incorrect version of software.
Z-2096-2025 · Root cause: Employee error · Recall details · FDA record ↗
- Nov 19, 2024Class IIOpen, Classified
Devices were identified as released after repair without full testing being performed, which includes flow testing.
Z-0776-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jul 17, 2024Class IIOpen, Classified
The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.
Z-2581-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jul 17, 2024Class IIOpen, Classified
The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.
Z-2582-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 15, 2023Class IOpen, Classified
A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.
Z-2103-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Dec 29, 2021Class IOpen, Classified
There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.
Z-0530-2022 · Root cause: Device Design · Recall details · FDA record ↗
- Nov 23, 2020Class IIOpen, Classified
There is a potential software error during programming.
Z-0714-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 30, 2020Class ITerminated
Baxter is updating the device IFU for safety communication regarding cleaning practices.
Z-0122-2021 · Root cause: Labeling design · Recall details · FDA record ↗
Most reported problems
Device problems
- Protective Measures Problem3,080
- False Alarm2,890
- Failure to Sense1,603
- Device Alarm System810
- Filling Problem778
- Defective Alarm735
- No Display/Image399
- Complete Loss of Power341
Patient problems
- No Clinical Signs, Symptoms or Conditions8,369
- No Patient Involvement2,011
- No Consequences Or Impact To Patient1,059
- No Known Impact Or Consequence To Patient69
- Low Blood Pressure/ Hypotension33
- Insufficient Information13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
- Cardiac Arrest4
Recent adverse event reports
The 25 most recent of 11,585 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951235 ↗MalfunctionSep 30, 2026Filling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949741 ↗MalfunctionSep 28, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923572 ↗MalfunctionSep 28, 2026Improper Flow or Infusion
Patient problems: Apnea; Bradycardia; Low Blood Pressure/ Hypotension
MAUDE report 50913376 ↗MalfunctionSep 25, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50901664 ↗MalfunctionSep 25, 2026False Alarm
It was reported that a Spectrum Pump alarmed constant downstream occlusion. This occurred during an unspecified process step. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900432 ↗MalfunctionSep 25, 2026False Alarm
It was reported that a Spectrum Pump had an air in line sensor failure during programming/setup. There was no patient involvement. No additional information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897845 ↗MalfunctionSep 24, 2026Protective Measures Problem
It was reported that a Spectrum Pump alarmed System Error 321 (Link Switch Error (Up)) during patient infusion. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880343 ↗MalfunctionSep 23, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875562 ↗MalfunctionSep 23, 2026Filling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875561 ↗MalfunctionSep 23, 2026Device Difficult to Program or Calibrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875556 ↗MalfunctionSep 23, 2026Filling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875442 ↗MalfunctionSep 21, 2026Device Difficult to Program or Calibrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847410 ↗MalfunctionSep 21, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845883 ↗MalfunctionSep 21, 2026False Alarm
It was reported that a Spectrum Pump alarmed downstream occlusion during programming/setup. There was no patient involvement. No additional information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842030 ↗MalfunctionSep 18, 2026Protective Measures Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830364 ↗MalfunctionSep 18, 2026Filling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829431 ↗MalfunctionSep 18, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829262 ↗MalfunctionSep 17, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805197 ↗MalfunctionSep 17, 2026False Alarm
It was reported that a Spectrum Pump alarmed constantly downstream occlusion occurred during an unspecified process step. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804405 ↗MalfunctionSep 17, 2026Excess Flow or Over-Infusion
It was reported that a Spectrum Pump infused too quickly (over infused) during patient infusion. The programmed infusion parameters were expected to be 30 mL volume to be infused, with the corresponding infusion time and flow rate set accordingly. However, the actual delivered volume was 300 mL. The patient was connected to the pump during the event. According to the clinician, the pump was programmed to infuse 30 mL, but 300 mL was delivered. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803888 ↗MalfunctionSep 16, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794673 ↗MalfunctionSep 16, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794447 ↗MalfunctionSep 16, 2026False Alarm
It was reported that a Spectrum Pump was unable to clear an upstream occlusion alarm. This occurred during an unspecified process step. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794409 ↗MalfunctionSep 16, 2026False Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794110 ↗
Other Infusion safety management software devices
- Spectrum IQ 3570009Baxter Healthcare Corporation · Infusion safety management software11 recalls10 deaths9,086 reports
- Alaris 8975Carefusion 303, Inc. · Infusion safety management software169 reports
- LifeShield Infusion Safety Software Suite 17003-02ICU Medical, Inc. · Infusion safety management software2 recalls0 reports
- Alaris 9601Carefusion 303, Inc. · Infusion safety management software2 recalls0 reports
- BD Alaris™ Infusion Adapter, Software Not ApplicableCarefusion 303, Inc. · Infusion safety management software1 recall0 reports
- LifeShield Infusion Safety Software Suite - LifeShield DLM 2.1Icu Medical, Inc. · Infusion safety management software1 recall0 reports
- BD Intelliport 516704Becton, Dickinson And Company · Infusion safety management software28 reports
- Ivenix Infusion System 030-0027-06Fresenius Kabi AG · Infusion Safety Management Software3 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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