Alaris™ Pump Module, Model 8100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5,636 adverse event reports that list this exact device (DI 10885403211423), received between Apr 13, 2021 and Sep 15, 2026 — classified as 2 deaths, 5 injuries, 5,629 malfunctions.

The most frequently reported specific device problem is “Corroded” (3,414 reports).

1 FDA recall record name this device's identifier, 1 still open.

35 other recalls cover devices cleared under the same FDA submission (K133532); 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 5,636 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Contamination

  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 50766771 ↗
• MalfunctionAug 6, 2026Contamination; Corroded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50152183 ↗
• MalfunctionMay 29, 2026Contamination; 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 25327972 ↗
• MalfunctionDec 4, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [REPAIR MULTI-DEVICE]; [REPAIR]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713606 ↗
• MalfunctionOct 16, 2025Contamination; Corroded; Crack; Device Sensing Problem; Contamination; 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 23309540 ↗
• MalfunctionAug 8, 2025Corroded; Device Sensing Problem; Corroded; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE HAD BOARD MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749986 ↗
• MalfunctionJul 30, 2025Break; Contamination; Corroded; Crack; Device Sensing Problem; Break; Contamination; Corroded; Crack; Device Sensing Problem

  IT WAS REPORTED THERE WAS A "PUMP ERROR" MESSAGE FOLLOWED BY "ERROR WITH TUBING" MESSAGE. PER REPORT, "WHEN OPENING THE CHANNEL, THE TUBING WAS FOUND SUCTIONED TO ITSELF". THE CLINICIAN SWITCHED THE CHANNEL AND OPENED AND CLOSED THE CLAMP ON TUBING TO FIX THE PRESSURE PROBLEM. FLUSHED WITH SHORT TUBING WITHOUT DIFFICULTY. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. ALTHOUGH REQUESTED NO ADDITIONAL INFORMATION WILL BE PROVIDED BY THE CUSTOMER, NO DEVICES WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22667878 ↗
• MalfunctionJul 11, 2025Contamination; Crack; Contamination; Crack

  IT WAS REPORTED THAT THE DEVICE HAD CRACKED HINGE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22477703 ↗
• MalfunctionJul 1, 2025Contamination; Crack; Contamination; Crack

  IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 221.2010 APPEARS UNIT AND SUSPECTED LOGIC BOARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370069 ↗
• MalfunctionJun 20, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE LARGE VOLUME PUMP MODULE WAS POSSIBLE PART OF AN OVER INFUSION EVENT. THERE WAS PATIENT INVOLVEMENT, BUT THE OUTCOME IS UNKNOWN. BD LEARNED ADDITIONAL INFORMATION AFTER A CPC CALL WITH THE CUSTOMER: ¿ BIOMED RAN THE PCU AND LVP THROUGH PM/CALIBRATION, NO ISSUES FOUND. ALARMS WERE TESTED, ALL OPERATED AS INTENDED. NO PHYSICAL DAMAGE WAS NOTED TO THE DEVICES. ¿ IT WAS SAID A PRIMARY INFUSION WAS TO INFUSE OVER 4 HOURS BUT THE BAG WAS FOUND EMPTY ABOUT 1 HOUR AND 45 MINUTES LATER WHEN AN AIR IN LINE ALARM OCCURRED. HOWEVER, BIOMED NOTED THEY DO NOT KNOW HOW MUCH FLUID WAS IN THE IV BAG AT THE START OF THE INFUSION. BIOMED QUESTIONED CLINICAL AND ASKED IF THEY HAD ENOUGH FLUID IN THE IV BAG TO LAST THE ENTIRE INFUSION. THE CLINICIANS MAINTAIN THAT THE PUMP ALLOWED MORE FLUID INTO THE PATIENT THAN INTENDED. ¿ THE PCU/LVP REMAIN SEQUESTERED. THE IV SET WAS DISCARDED AND IS NOT AVAILABLE FOR INVESTIGATION. BIOMED DOES NOT INTEND TO RETURN THE DEVICES TO BD.

  Patient problems: Insufficient Information

  MAUDE report 22296330 ↗
• MalfunctionJun 5, 2025Contamination; Corroded; Crack; Device Sensing Problem; Contamination; Corroded; Crack; Device Sensing Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153096 ↗
• MalfunctionMay 29, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE DEVICE PUMP WAS TOO LOUD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22111612 ↗
• MalfunctionMay 21, 2025Corroded; Crack; Corroded; Crack

  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 22064166 ↗
• MalfunctionMay 12, 2025Crack; Excess Flow or Over-Infusion; Device Sensing Problem; Crack; Excess Flow or Over-Infusion; Device Sensing Problem

  IT WAS REPORTED THERE WAS AN OVER INFUSION EVENT. INFUSION INITIATED AT 1346 AND THE CONTAINER EMPTIED AT 1405. UPON OBSERVATION, THE PUMP WAS SET AT THE RIGHT RATE AND VOLUME, HOWEVER THE INFUSION FINISHED 11 MINUTES EARLY. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22000752 ↗
• MalfunctionMay 5, 2025Display Difficult to Read; Display Difficult to Read

  IT WAS REPORTED THAT THE DEVICE DISPLAY BOARD IS MISSING A SEGMENT, FAULTY PATIENT AND FLUID SIDE PRESSURE SENSORS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959205 ↗
• MalfunctionApr 24, 2025Break; Corroded; Device Sensing Problem; Break; Corroded; Device Sensing Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21899120 ↗
• MalfunctionApr 23, 2025Crack; Crack

  IT WAS REPORTED THAT THE DEVICE HAD MISSING DISPLAY SEGMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21890697 ↗
• MalfunctionApr 21, 2025Break; Contamination; Corroded; Crack; Peeled/Delaminated; No Audible Prompt/Feedback; Break; Contamination; Corroded; Crack; Peeled/Delaminated; No Audible Prompt/Feedback

  IT WAS REPORTED BY THE CUSTOMER THAT THE NURSE PROGRAMMED AN INFUSION OF MAGNESIUM SULFATE FOR ONE HOUR. A LITTLE AFTER THE ONE HOUR MARK, THEY NOTICED THE PUMP WAS NOT BEEPING AND WENT TO CHECK ON THE PATIENT. THE NURSE NOTICED THE TOP OF THE TUBING WAS DRY/EMPTY WHILE THE LOWER HALF OF THE TUBING, BELOW THE CHAMBER AND SENSOR, WAS ALSO DRY; STATING THERE WAS ONLY FLUID 2-3 INCHES FROM THE PIV. THE PUMP MODULE HAD TO BE STOPPED BEFORE IT INFUSED AIR INTO THE PATIENT. THE SAFEGUARD DID NOT GO OFF AND THE AIR MADE IT PAST THE SENSOR. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21871446 ↗
• MalfunctionFeb 19, 2025Contamination; Corroded; Contamination; Corroded

  IT WAS REPORTED THAT THE DEVICE HAD CRACKED HINGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411481 ↗
• MalfunctionJan 20, 2025Break; Contamination; Corroded; Break; Contamination; Corroded

  IT WAS REPORTED THAT THE DEVICE HAD UNKNOWN OR UNSPECIFIED ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190841 ↗
• MalfunctionJan 13, 2025Break; Contamination; Corroded; Crack; Display Difficult to Read; Break; Contamination; Corroded; Crack; Display Difficult to Read

  IT WAS REPORTED THAT THE DEVICE HAD 242 MOTOR ERROR AND DISPLAY WAS MISSING SEGMENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21134809 ↗
• MalfunctionDec 27, 2024Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [REPAIR MULTI-DEVICE];[REPAIR]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025792 ↗
• MalfunctionDec 26, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE ALARMS THAT IT IS OCCLUDED BEFORE ANYTHING HAS BEEN PUMPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21017744 ↗
• MalfunctionDec 6, 2024Contamination; Contamination

  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 20865909 ↗
• MalfunctionNov 29, 2024Corroded; Corroded

  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 20810081 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133532. One submission often covers many models, so check the product and lot details in each record.

• Z-1645-2026 · Feb 11, 2026 · Open, Classified
  BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
• Z-0186-2024 · Sep 15, 2023 · Open, Classified
  Alaris PCA Module 8120
• Z-0184-2024 · Sep 15, 2023 · Open, Classified
  BD Alaris PCU REF 8015
• Z-0185-2024 · Sep 15, 2023 · Open, Classified
  BD Alaris Syringe Module, REF 8110
• Z-1544-2021 · Mar 26, 2021 · Open, Classified
  Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
• Z-1651-2021 · Mar 25, 2021 · Open, Classified
  Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
• Z-1375-2021 · Mar 24, 2021 · Open, Classified
  Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
• Z-1309-2021 · Mar 3, 2021 · Open, Classified
  BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
• Z-1543-2021 · Feb 26, 2021 · Terminated
  Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
• Z-1331-2021 · Feb 25, 2021 · Terminated
  Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
• Z-2204-2021 · Feb 25, 2021 · Terminated
  Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
• Z-1332-2021 · Feb 25, 2021 · Terminated
  Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
• Z-2910-2020 · Aug 4, 2020 · Open, Classified
  PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2,
• Z-2939-2020 · Aug 4, 2020 · Open, Classified
  BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
• Z-2882-2020 · Aug 4, 2020 · Open, Classified
  BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652

…and 20 more.