Alaris 8100 (UDI 10885403222054)Recalls & reported problems

Summary

The FDA's MAUDE database contains 650,218 adverse event reports that list this exact device (DI 10885403222054), received between Jul 16, 2018 and Jul 30, 2026 — classified as 2 deaths, 31 injuries, 650,185 malfunctions.

The most frequently reported specific device problem is “Crack” (643,229 reports).

2 FDA recall records name this device's identifier, 2 still open.

12 other recalls cover devices cleared under the same FDA submission (K950419); they may or may not involve this specific model.

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.

Recalls naming this device

1. 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 ↗

2. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 650,218 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Contamination; Corroded; Crack; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50083066 ↗
• MalfunctionJul 29, 2026Break; Contamination; Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50064747 ↗
• MalfunctionJul 28, 2026Break; Contamination; Crack

  It was reported that the device was not turning on. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50049416 ↗
• MalfunctionJul 27, 2026Contamination; Crack; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50035885 ↗
• MalfunctionJul 27, 2026Contamination; Corroded; Crack; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50025330 ↗
• MalfunctionApr 8, 2026Contamination; Corroded

  IT WAS REPORTED THAT THE DEVICE HAD CHANNEL ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815112 ↗
• MalfunctionMar 31, 2026Contamination; Corroded

  IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 211.2000. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741228 ↗
• MalfunctionMar 12, 2026Corroded

  IT WAS REPORTED THAT THE DEVICE HAD BROKEN BEZEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578874 ↗
• MalfunctionMar 11, 2026Contamination; Crack; Peeled/Delaminated

  IT WAS REPORTED THAT THE DEVICE HAD BROKEN BEZEL. THERE WAS NO PATIENT INVOLVEMENT.UT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567199 ↗
• MalfunctionMar 11, 2026Contamination; Corroded; Crack; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE HAD CHANNEL ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567193 ↗
• MalfunctionOct 15, 2025Corroded; Crack; Device Sensing Problem; Corroded; Crack; Device Sensing Problem

  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 23287891 ↗
• MalfunctionSep 5, 2025Contamination; Crack; Contamination; 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 22975123 ↗
• MalfunctionSep 4, 2025Contamination; Crack; Contamination; 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 22960494 ↗
• MalfunctionSep 2, 2025Corroded; Crack; Device Sensing Problem; Corroded; Crack; Device 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 22936293 ↗
• MalfunctionAug 28, 2025Corroded; Crack; Corroded; Crack

  IT WAS REPORTED THAT THE DEVICE NEEDS CALIBRATION ERROR MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911749 ↗
• MalfunctionAug 22, 2025Contamination; Failure to Sense; Contamination; Failure to Sense

  IT WAS REPORTED THAT THE DEVICE HAD AN ERROR CODE 242.403. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22871144 ↗
• MalfunctionJul 21, 2025Contamination; Corroded; Device Sensing Problem; Contamination; Corroded; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE HAD CHANNEL ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553970 ↗
• MalfunctionJul 1, 2025Crack; Device Sensing Problem; Crack; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE HAD PRESSURE IS OUT SPECIFICATIONS AND UNABLE TO CALIBRATE UNIT AFTER MULTIPLE TIMES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370093 ↗
• MalfunctionJun 5, 2025Break; Corroded; Crack; Break; Corroded; Crack

  IT WAS REPORTED THAT THE DEVICE HAD DISPLAYED AN ERROR CODE 242.4030. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153137 ↗
• MalfunctionMay 29, 2025Break; Contamination; Corroded; Device Sensing Problem; Break; Contamination; Corroded; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE HAD CHECK IV ERROR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22111556 ↗
• MalfunctionMay 29, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE DEVICE HAD CHANNEL ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105041 ↗
• MalfunctionApr 30, 2025Contamination; Crack; Insufficient Flow or Under Infusion; Contamination; Crack; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT INFUSION WAS PROGRAMMED AT 1242 TO RUN FOR 180 MINUTES, HOWEVER THIRTY-TWO (32) MINUTES OVER THE PROGRAMMED TIME, FINISHING AT 1614. VOLUME DID HAVE TO BE ADDED TO THE VTBI THREE TIMES, AS IT SAID "VOLUME COMPLETE" BUT THERE WAS STILL DRUG REMAINING IN THE BAG AND THE TUBING. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932341 ↗
• MalfunctionApr 25, 2025Contamination; Excess Flow or Over-Infusion; Contamination; Excess Flow or Over-Infusion

  IT WAS REPORTED BY CUSTOMER "1 BAG OF IV POTASSIUM WAS STARTED AT 1220 FOR THIS PATIENT BY RN. CHANNEL WAS PROGRAMMED AT ORDERED RATE OF5 50ML/HR. BAG WOULD RUN OVER 1 HOUR. STARTED INFUSION AND LEFT ROOM. HEARD IV PUMP ALARMING AT 1248. NOTED CHANNEL RUNNING POTASSIUM WAS ALARMING. NOTED AIR IN LINE ALARM. NOTED POTASSIUM BAG TO BE COMPLETELY EMPTY. PAUSED INFUSION AND CHECKED FOR CONFIRMATION THAT PUMP WAS PROGRAMMED CORRECTLY BY RN. IT WAS VERIFIED THAT THE PUMP WAS PROGRAMMED CORRECTLY. THE PATIENT WAS NOT INJURED. CUSTOMER IS REQUESTING A WRITTEN REPORT. CUSTOMER REPORT: (B)(4)". THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21906227 ↗
• MalfunctionMar 25, 2025Break; Contamination; Corroded; Crack; Break; Contamination; Corroded; Crack

  IT WAS REPORTED THAT THE DEVICE HAD CHANNEL ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688915 ↗
• MalfunctionMar 20, 2025Corroded; Crack; Corroded; Crack

  IT WAS REPORTED THAT THE DEVICE HAD CHANNEL ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651490 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K950419. One submission often covers many models, so check the product and lot details in each record.

• Z-0026-2018 · Aug 9, 2017 · Open, Classified
  Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 a
• Z-2700-2017 · Jun 12, 2017 · Terminated
  Alaris Pump Module model 8100
• Z-0950-2017 · Dec 2, 2016 · Terminated
  Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. Th
• Z-1567-2014 · Apr 23, 2014 · Terminated
  Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion p
• Z-2185-2012 · Jun 29, 2012 · Terminated
  Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and b
• Z-2205-2012 · Jun 15, 2012 · Terminated
  Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of flu
• Z-1793-2009 · Jun 12, 2009 · Terminated
  Alaris Pump Module, Model 8100.
• Z-1794-2009 · Jun 12, 2009 · Terminated
  Alaris System Inter-Unit Interface (IUI) Connectors. The Modules include the following: Alaris PC Unit, Model Numbers 8000 and 8015; Alaris Pump Module, Model 8100; Alaris Patien
• Z-1711-2008 · Mar 5, 2008 · Terminated
  Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March 26, 2004: (1) Alaris PC point-of-care unit ("PC Unit") (Model 8000)* (
• Z-1710-2008 · Mar 5, 2008 · Terminated
  U19 Socketed Integrated Circuit ("U19 IC") on the logic board of Alaris Pump modules (aka. Medley Pump modules), Model 8100 built on or before September 8, 2005. CardinalHealth, S
• Z-1712-2008 · Mar 5, 2008 · Terminated
  U9 Socket Integrated Circuit ("U9 IC") on the display board of the following Alaris System modules built on or before October 4, 2005: (1) Alaris Syringe module (Model 8110) (a.k.a
• Z-0568-05 · Nov 10, 2004 · Terminated
  Model 8100 Series Medley Medication Safety System Pump Module