Alaris 8600Recalls & reported problems
Carefusion 303, Inc. · Alaris Auto-ID Module (v8) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Alaris 8600 infusion pump has 194 reports and no injuries or deaths. Many reports describe cracked or broken casings and circuit failures, often found during routine servicing, and many note that no patient was involved. No recalls name this device.
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
- 194
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 194 adverse event reports that list this exact device (DI 10885403860003), received between Feb 27, 2018 and Jun 16, 2026 — classified as 194 malfunctions.
The most frequently reported specific device problem is “Crack” (67 reports).
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
Most reported problems
Device problems
- Crack67
- Circuit Failure45
- Break41
- Corroded27
- Appropriate Device Problem Term/Code Not Available20
- Contamination10
- Failure to Read Input Signal10
- Output Problem10
Patient problems
- No Clinical Signs, Symptoms or Conditions109
- No Patient Involvement77
- No Known Impact Or Consequence To Patient5
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 25 most recent of 194 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2026Break; Crack
IT WAS REPORTED THAT THE DEVICE HAD BROKEN CASE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25513969 ↗MalfunctionDec 30, 2025Break; Corroded; Break; Corroded
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 23920302 ↗MalfunctionNov 19, 2025Corroded; Corroded
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 23594797 ↗MalfunctionMar 28, 2025Break; Contamination; Break; Contamination
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 21717593 ↗MalfunctionJan 7, 2025Contamination; Contamination
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 21091642 ↗MalfunctionNov 20, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THE 8600 LED LIGHT WAS NOT FLASHING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20732017 ↗MalfunctionMay 22, 2024Break; Crack; Break; Crack
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 19373583 ↗MalfunctionMay 22, 2024Break; Crack; Break; Crack
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 19373574 ↗MalfunctionFeb 15, 2024Break; Crack; Failure to Read Input Signal; Break; Crack; Failure to Read Input Signal
IT WAS REPORTED THAT THE "BUTTON TO SCAN BADGE DOES NOT ALWAYS WORK." THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18710145 ↗MalfunctionDec 26, 2023Contamination; No Apparent Adverse Event; Physical Resistance/Sticking; Contamination; No Apparent Adverse Event; Physical Resistance/Sticking
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 18390712 ↗MalfunctionDec 25, 2023Contamination; No Apparent Adverse Event; Contamination; No Apparent Adverse Event
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 18390383 ↗MalfunctionNov 16, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE DEVICE DAMAGED HOUSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18154970 ↗MalfunctionNov 16, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE DEVICE HAD DAMAGED HOUSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18150910 ↗MalfunctionNov 16, 2023Break; Crack; Communication or Transmission Problem; Break; Crack; Communication or Transmission Problem
IT WAS REPORTED THAT THE DEVICE HAD DAMAGED HOUSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18150893 ↗MalfunctionOct 6, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
IT WAS REPORTED THAT THE DEVICE HAD DISPLAYED AN ALARM - ERROR CODES / MESSAGES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17892416 ↗MalfunctionAug 18, 2023Break; Crack; No Apparent Adverse Event; Break; Crack; No Apparent Adverse Event
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 17570553 ↗MalfunctionJul 19, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE DEVICE HAD RATTLING INSIDE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17353356 ↗MalfunctionJun 29, 2023Circuit Failure; Circuit Failure
IT WAS REPORTED THAT THE DEVICE DISPLAYED ALARM - ERROR CODES / MESSAGES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17230685 ↗MalfunctionJun 29, 2023Circuit Failure; Circuit Failure
IT WAS REPORTED THAT THE DEVICE DISPLAYED ALARM - ERROR CODES / MESSAGES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17230673 ↗MalfunctionJun 29, 2023Circuit Failure; Circuit Failure
IT WAS REPORTED THAT THE DEVICE HAD SOFTWARE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17230619 ↗MalfunctionJun 29, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE DEVICE HAD DISPLAY / SCREEN ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17226723 ↗MalfunctionJun 2, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE DEVICE HAD BROKEN / DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17049414 ↗MalfunctionJun 1, 2023Circuit Failure; Application Program Problem; Circuit Failure; Application Program Problem
IT WAS REPORTED THAT THE DEVICE HAD ALARM ERROR CODES/ MESSAGES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17035755 ↗MalfunctionMay 31, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE DEVICE HAD BROKEN / DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17028568 ↗MalfunctionMay 22, 2023No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE DEVICE HAD FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16973266 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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