Alaris, SmartSite 2426-0500Recalls & reported problems

Summary

The FDA's MAUDE database contains 753 adverse event reports that list this exact device (DI 07613203020992), received between Mar 9, 2016 and Jul 6, 2026 — classified as 4 deaths, 18 injuries, 730 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (288 reports).

2 FDA recall records name this device's identifier, 1 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.

Recalls naming this device

1. Sep 11, 2025Class IOpen, 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-0035-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 6, 2019Class ITerminated

   An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.

   Z-1770-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 753 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026Crack

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN REGARDS TO ITEM #'S 2426-0500 AND 2426-0007. HAVE SEEN ISSUES INVOLVING CRACKING AT THE TUBING CONNECTION SITE WHEN USED WITH NEXUS CAPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25719094 ↗
• MalfunctionAug 15, 2025Leak/Splash; Leak/Splash

  SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22821554 ↗
• MalfunctionAug 15, 2025Leak/Splash; Leak/Splash

  SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22821553 ↗
• MalfunctionJul 8, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS SEPARATED, THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THEY HAD AN ADDITIONAL IV TUBING COME APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436324 ↗
• MalfunctionJul 8, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE IV TUBING COME APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435157 ↗
• MalfunctionJul 3, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT IV TUBING LEAKING. THIS CONNECTION IS NOT COMPLETELY SEPARATED, BUT BARELY CONNECTED, THUS THE FLUID LEAKS OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401264 ↗
• MalfunctionJun 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE IV TUBING CAME APART AT ONE OF THE JUNCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22188085 ↗
• MalfunctionJun 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT PRIMARY TUBING WAS LEAKING/CRACKED AT WHERE WE BELIEVE THE BLUE SLIDE CLAMP WAS ENGAGED ON THE TUBING. THESE WERE CHEMOTHERAPY PREPARATIONS WHERE PHARMACY PRIMES THE TUBING IN THE CLEANROOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180241 ↗
• MalfunctionJun 4, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT NURSE SPIKED THE BOTTLE AND WAS ABOUT TO SQUEEZE THE DRIP CHAMBER AND NOTICED TWO LONG CRACKS ON THE CHAMBER. THE TUBING FELL APART INTO 3 SEPARATE SEGMENTS. THE NURSE DID NOT APPLY ANY UNORDINARY FORCE TO THE TUBING DURING HANDLING. THE NURSE MANAGER INSPECTED IT AND FOUND IT HAD SEPARATED AT THE BACKFLOW VALVE JUST BENEATH THE DRIP CHAMBER. THE NURSE DID NOT APPLY ANY UNORDINARY FORCE TO THE TUBING DURING HANDLING. THE NURSE MANAGER INSPECTED IT AND FOUND IT HAD SEPARATED AT THE BACKFLOW VALVE JUST BENEATH THE DRIP CHAMBER. IT ALSO SEPARATED AT THE LAST Y-SITE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144570 ↗
• MalfunctionJun 4, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT NURSE SPIKED THE BOTTLE AND WAS ABOUT TO SQUEEZE THE DRIP CHAMBER AND NOTICED TWO LONG CRACKS ON THE CHAMBER. THE TUBING FELL APART INTO 3 SEPARATE SEGMENTS. THE NURSE DID NOT APPLY ANY UNORDINARY FORCE TO THE TUBING DURING HANDLING. THE NURSE MANAGER INSPECTED IT AND FOUND IT HAD SEPARATED AT THE BACKFLOW VALVE JUST BENEATH THE DRIP CHAMBER. THE NURSE DID NOT APPLY ANY UNORDINARY FORCE TO THE TUBING DURING HANDLING. THE NURSE MANAGER INSPECTED IT AND FOUND IT HAD SEPARATED AT THE BACKFLOW VALVE JUST BENEATH THE DRIP CHAMBER. IT ALSO SEPARATED AT THE LAST Y-SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142910 ↗
• MalfunctionMay 6, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT BD ALARIS PUMP INFUSION SET TUBING MALFUNCTION. THE MALE LUER END DISCONNECTED FROM THE PRIMARY TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972957 ↗
• MalfunctionFeb 12, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21365106 ↗
• MalfunctionFeb 9, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THEY STATED JUST ABOVE THE JUNCTION THE TUBING WAS LEAKING AND AS THEY WENT TO REMOVE THE TUBING IT FELL APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21340829 ↗
• MalfunctionJan 31, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT BD ALARIS PUMP INFUSION SET CONNECTED TO MEDICATION BAG AND UNABLE TO FREE FLOW PRIME TUBE. ATTEMPTED TO FLUSH TUBING WITH NS SYRINGE AND UNABLE TO FLUSH. TUBING DISCONNECTED AND NEW TUBING APPLIED WITHOUT INCIDENT. I HAVE THE TUBING AND PACKAGING. WHERE WOULD YOU LIKE ME TO SEND THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285254 ↗
• MalfunctionDec 29, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING WAS THEN LOADED INTO THE IV PUMP AND CONNECTED TO THE PATIENT. THE RN STARTED THE INFUSION AND NOTICED THAT THE IV TUBING WAS BACK FILLING WITH THE PATIENT'S BLOOD. THE IV INFUSION WAS PAUSED, AND THE RN FLUSHED THE TUBING WITH A 10CC NS FLUSH THROUGH ONE OF THE IV PORTS ON THE TUBING. WHEN THE RN FLUSHED THE TUBING, HE NOTICED THAT THERE WAS FLUID LEAKING FROM THE TUBING. THE RN THEN DISCONNECTED THE TUBING FROM THE PATIENT AND INSPECTED THE TUBING AND LOCATED A DEFECT WHERE THERE WAS A HOLE IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032673 ↗
• MalfunctionNov 19, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723955 ↗
• MalfunctionNov 13, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE LEAKING OCCURS AT THE CONNECTION SITE BETWEEN THE TEXIUM SECONDARY INFUSION SET AND THE UPPERMOST ALARIS PRIMARY INFUSION SET Y-SITE. THE LEAK CONSISTS OF A SMALL AMOUNT OF DROPLETS FORMING DURING THE INFUSION. IT HAS OCCURRED FROM THE POINT OF 30 MINUTES INTO THE INFUSION TO 45-95 MINUTES OF AN INFUSION. THERE IS NO COMMONALITY OF BASE OR DRUG SOLUTIONS CAUSING THE LEAK. IT HAS OCCURRED A TOTAL OF 5 TIMES IN THE LAST 6 BUSINESS DAYS. OUR FACILITY USES ALARIS PUMPS WHICH ARE CURRENTLY MAINTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674084 ↗
• MalfunctionNov 13, 2024Leak/Splash; Leak/Splash

  MATERIAL #:2426-0500. BATCH#:1024083015, 1024083012, 1024073140, 1024073135, 1024063259, 1024093001. IT WAS REPORTED BY CUSTOMER THAT THE LEAKING OCCURS AT THE CONNECTION SITE BETWEEN THE TEXIUM SECONDARY INFUSION SET AND THE UPPERMOST ALARIS PRIMARY INFUSION SET Y-SITE. THE LEAK CONSISTS OF A SMALL AMOUNT OF DROPLETS FORMING DURING THE INFUSION. IT HAS OCCURRED FROM THE POINT OF 30 MINUTES INTO THE INFUSION TO 45-95 MINUTES OF AN INFUSION. THERE IS NO COMMONALITY OF BASE OR DRUG SOLUTIONS CAUSING THE LEAK. IT HAS OCCURRED A TOTAL OF 5 TIMES IN THE LAST 6 BUSINESS DAYS. OUR FACILITY USES ALARIS PUMPS WHICH ARE CURRENTLY MAINTAINED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I HAVE INCLUDED A LIST OF SUSPECTED LOT NUMBERS ASSOCIATED WITH THE PROBLEM. THE LEAKING OCCURS AT THE CONNECTION SITE BETWEEN THE TEXIUM SECONDARY INFUSION SET AND THE UPPERMOST ALARIS PRIMARY INFUSION SET Y-SITE. THE LEAK CONSISTS OF A SMALL AMOUNT OF DROPLETS FORMING DURING THE INFUSION. IT HAS OCCURRED FROM THE POINT OF 30 MINUTES INTO THE INFUSION TO 45-95 MINUTES OF AN INFUSION. THERE IS NO COMMONALITY OF BASE OR DRUG SOLUTIONS CAUSING THE LEAK. IT HAS OCCURRED A TOTAL OF 5 TIMES IN THE LAST 6 BUSINESS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674072 ↗
• MalfunctionNov 13, 2024Leak/Splash; Leak/Splash

  MATERIAL #: 2426-0500 & BATCH #:1024083015, 1024083012, 1024073140, 1024073135, 1024063259 & 1024093001. IT WAS REPORTED BY CUSTOMER THAT THE LEAKING OCCURS AT THE CONNECTION SITE BETWEEN THE TEXIUM SECONDARY INFUSION SET AND THE UPPERMOST ALARIS PRIMARY INFUSION SET Y-SITE. THE LEAK CONSISTS OF A SMALL AMOUNT OF DROPLETS FORMING DURING THE INFUSION. IT HAS OCCURRED FROM THE POINT OF 30 MINUTES INTO THE INFUSION TO 45-95 MINUTES OF AN INFUSION. THERE IS NO COMMONALITY OF BASE OR DRUG SOLUTIONS CAUSING THE LEAK. IT HAS OCCURRED A TOTAL OF 5 TIMES IN THE LAST 6 BUSINESS DAYS. OUR FACILITY USES ALARIS PUMPS WHICH ARE CURRENTLY MAINTAINED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I HAVE INCLUDED A LIST OF SUSPECTED LOT NUMBERS ASSOCIATED WITH THE PROBLEM. THE LEAKING OCCURS AT THE CONNECTION SITE BETWEEN THE TEXIUM SECONDARY INFUSION SET AND THE UPPERMOST ALARIS PRIMARY INFUSION SET Y-SITE. THE LEAK CONSISTS OF A SMALL AMOUNT OF DROPLETS FORMING DURING THE INFUSION. IT HAS OCCURRED FROM THE POINT OF 30 MINUTES INTO THE INFUSION TO 45-95 MINUTES OF AN INFUSION. THERE IS NO COMMONALITY OF BASE OR DRUG SOLUTIONS CAUSING THE LEAK. IT HAS OCCURRED A TOTAL OF 5 TIMES IN THE LAST 6 BUSIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674041 ↗
• MalfunctionNov 13, 2024Leak/Splash; Leak/Splash

  MATERIAL#:2426-0500, BATCH#:1024083015, 1024083012, 1024073140, 1024073135, 1024063259, 1024093001. IT WAS REPORTED BY CUSTOMER THAT THE LEAKING OCCURS AT THE CONNECTION SITE BETWEEN THE TEXIUM SECONDARY INFUSION SET AND THE UPPERMOST ALARIS PRIMARY INFUSION SET Y-SITE. THE LEAK CONSISTS OF A SMALL AMOUNT OF DROPLETS FORMING DURING THE INFUSION. IT HAS OCCURRED FROM THE POINT OF 30 MINUTES INTO THE INFUSION TO 45-95 MINUTES OF AN INFUSION. THERE IS NO COMMONALITY OF BASE OR DRUG SOLUTIONS CAUSING THE LEAK. IT HAS OCCURRED A TOTAL OF 5 TIMES IN THE LAST 6 BUSINESS DAYS. OUR FACILITY USES ALARIS PUMPS WHICH ARE CURRENTLY MAINTAINED. RCC RECEIVED A COMPLAINT VIA EMAIL. I HAVE INCLUDED A LIST OF SUSPECTED LOT NUMBERS ASSOCIATED WITH THE PROBLEM. THE LEAKING OCCURS AT THE CONNECTION SITE BETWEEN THE TEXIUM SECONDARY INFUSION SET AND THE UPPERMOST ALARIS PRIMARY INFUSION SET Y-SITE. THE LEAK CONSISTS OF A SMALL AMOUNT OF DROPLETS FORMING DURING THE INFUSION. IT HAS OCCURRED FROM THE POINT OF 30 MINUTES INTO THE INFUSION TO 45-95 MINUTES OF AN INFUSION. THERE IS NO COMMONALITY OF BASE OR DRUG SOLUTIONS CAUSING THE LEAK. IT HAS OCCURRED A TOTAL OF 5 TIMES IN THE LAST 6 BUSINESS DAYS. OUR F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674032 ↗
• MalfunctionNov 13, 2024Leak/Splash; Leak/Splash

  MATERIAL #:(B)(4). BATCH#:1024083015, 1024083012, 1024073140, 1024073135, 1024063259, AND 1024093001. IT WAS REPORTED BY CUSTOMER THAT THE LEAKING OCCURS AT THE CONNECTION SITE BETWEEN THE TEXIUM SECONDARY INFUSION SET AND THE UPPERMOST ALARIS PRIMARY INFUSION SET Y-SITE. THE LEAK CONSISTS OF A SMALL AMOUNT OF DROPLETS FORMING DURING THE INFUSION. IT HAS OCCURRED FROM THE POINT OF 30 MINUTES INTO THE INFUSION TO 45-95 MINUTES OF AN INFUSION. THERE IS NO COMMONALITY OF BASE OR DRUG SOLUTIONS CAUSING THE LEAK. IT HAS OCCURRED A TOTAL OF 5 TIMES IN THE LAST 6 BUSINESS DAYS. OUR FACILITY USES ALARIS PUMPS WHICH ARE CURRENTLY MAINTAINED. VERBATIM: (B)(6) RECEIVED A COMPLAINT VIA EMAIL. I HAVE INCLUDED A LIST OF SUSPECTED LOT NUMBERS ASSOCIATED WITH THE PROBLEM. THE LEAKING OCCURS AT THE CONNECTION SITE BETWEEN THE TEXIUM SECONDARY INFUSION SET AND THE UPPERMOST ALARIS PRIMARY INFUSION SET Y-SITE. THE LEAK CONSISTS OF A SMALL AMOUNT OF DROPLETS FORMING DURING THE INFUSION. IT HAS OCCURRED FROM THE POINT OF 30 MINUTES INTO THE INFUSION TO 45-95 MINUTES OF AN INFUSION. THERE IS NO COMMONALITY OF BASE OR DRUG SOLUTIONS CAUSING THE LEAK. IT HAS OCCURRED A TOTAL OF 5 TIMES IN THE LAST 6 BUSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674031 ↗
• MalfunctionNov 13, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE LEAKING OCCURS AT THE CONNECTION SITE BETWEEN THE TEXIUM SECONDARY INFUSION SET AND THE UPPERMOST ALARIS PRIMARY INFUSION SET Y-SITE. THE LEAK CONSISTS OF A SMALL AMOUNT OF DROPLETS FORMING DURING THE INFUSION. IT HAS OCCURRED FROM THE POINT OF 30 MINUTES INTO THE INFUSION TO 45-95 MINUTES OF AN INFUSION. THERE IS NO COMMONALITY OF BASE OR DRUG SOLUTIONS CAUSING THE LEAK. IT HAS OCCURRED A TOTAL OF 5 TIMES IN THE LAST 6 BUSINESS DAYS. OUR FACILITY USES ALARIS PUMPS WHICH ARE CURRENTLY MAINTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674026 ↗
• MalfunctionOct 23, 2024

  TOOK PRIMARY TUBING OUT OF PACKAGE AND WAS PRIMING INFUSION WHEN NOTICED THAT THE TUBING WAS LEAKING AT THE PORTS. WHEN WE INSPECTED IT FURTHER, YOU COULD SEE MICRO-CRACKS IN THE TUBING. TUBING WAS NEVER CONNECTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513807 ↗
• MalfunctionSep 24, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS BULGING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT ONE NURSE HAD A HUGE BALLOON IN THE STRETCHY PART THAT ENDED UP POPPING. THE OTHER NURSE HAD THE TUBING COMPLETELY DISCONNECT AND TPN WENT FLYING EVERYWHERE.

  Patient problems: Insufficient Information

  MAUDE report 20297625 ↗
• MalfunctionSep 24, 2024Material Separation; Material Separation

  NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 20297571 ↗