Alaris, SmartSite 2420-0500Recalls & reported problems

Summary

The FDA's MAUDE database contains 642 adverse event reports that list this exact device (DI 07613203012430), received between May 12, 2017 and Mar 5, 2026 — classified as 1 death, 11 injuries, 630 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (253 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. Aug 19, 2026Class IOpen, Classified

   Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.

   Z-3080-2026 · Root cause: Device Design · 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 642 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Leak/Splash; Material Puncture/Hole

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24515596 ↗
• MalfunctionMay 23, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT BD ALARIS SMARTSITE INFUSION SET WAS MISSING A COMPONENT THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT IV TUBING PACKAGING WAS FOUND TO HAVE RIPPED AND THE TUBING HAD HOLES IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077828 ↗
• MalfunctionMay 21, 2025Material Discolored; Material Discolored

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS DISCOLORED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIMIT WAS REPORTED BY CUSTOMER THAT DISCOLORED TUBING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062367 ↗
• MalfunctionMay 17, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  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 IV TUBING PACKAGING WAS FOUND TO HAVE RIPPED AND THE TUBING HAD HOLES IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041241 ↗
• MalfunctionMay 17, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE 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 PACKAGING WAS FOUND TO HAVE RIPPED AND THE TUBING HAD HOLES IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041240 ↗
• MalfunctionMay 6, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOR LOT # (10)24083199, OUR NURSING STAFF COMPLAINED THAT SET WOULD NOT PRIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971923 ↗
• MalfunctionMar 28, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD FOREIGN MATTER THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: REPORTED ISSUE: ON (B)(6) 2025, DURING THE MORNING MEDICATION PASS, A BEDSIDE NURSE DISCOVERED A SEALED INFUSION SET CONTAINING A HAIR. THE INCIDENT WAS PROMPTLY REPORTED TO THE HOUSE SUPERVISOR, WHO ADVISED THAT THE PRODUCT BE RETURNED TO THE DISTRIBUTION DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21727197 ↗
• MalfunctionMar 17, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS OVER INFUSING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: THE INCIDENT OCCURRED DURING DAYSHIFT IN THE MEDICAL- SURGICAL UNIT. (B)(6), AN EXPERIENCED TRAVEL NURSE, WAS ASSIGNED TO THE PATIENT THAT DAY. A 1000ML BAG OF NORMAL SALINE WAS HUNG AS THE PRIMARY LINE, WITH A ROCEPHIN (1G/50ML) BAG PIGGY BACKED INTO THE NORMAL SALINE LINE AND IT WAS ATTACHED AT THE SMARTSITE VALVE DIRECTLY ABOVE THE ALARIS SYSTEM. ADDITIONALLY, A SEPARATE PRIMARY LINE WAS HUNG FOR A MAGNESIUM SULFATE INFUSION, WHICH WAS Y-SITED INTO THE NORMAL SALINE LINE AT THE SMARTSITE VALVE CLOSEST TO THE PATIENT. THE ROCEPHIN INFUSION WAS PROGRAMMED MANUALLY USING GUARDRAILS TO INFUSE AT 100ML/HR OVER 30 MINUTES. (B)(6) COULD NOT RECALL THE INFUSION RATE OF THE MAGNESIUM SULFATE AT THE TIME OF THE EVENT. PER HOSPITAL PROTOCOL, THE NORMAL SALINE INFUSION ON THE PRIMARY LINE WAS TURNED OFF WHEN THE ROCEPHIN INFUSION BEGAN. ONCE THE PIGGYBACK INFUSION COMPLETES, THE HOSPITAL PROTOCOL IS TO TURN THE NORMAL SALINE LINE BACK ON TO SERVE AS A FLUSH BAG. (B)(6) STATED THAT THE ALARIS SYSTEM DEVICE WAS POSITIONED AT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621483 ↗
• MalfunctionMar 17, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS MISSING COMPONENT THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. BD ALARIS PUMP INFUSION SET WITH BACK CHECK VALVE. ROLLER CLAMP NOT INCLUDED ON TUBING. NO WAY TO CLAMP LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617517 ↗
• MalfunctionMar 12, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS MISSING A COMPONENT THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT NURSE NOTICED, PRIOR TO SPIKING MEDICATION WITH TUBING, THAT THE BD ALARIS PUMP INFUSION SET BACK CHECK VALVE WAS MISSING THE ROLLER CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590554 ↗
• MalfunctionFeb 18, 2025

  REGISTERED NURSE NOTICED, PRIOR TO SPIKING MEDICATION WITH TUBING, THAT THE BD ALARIS PUMP INFUSION SET BACK CHECK VALVE WAS MISSING THE ROLLER CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392115 ↗
• MalfunctionFeb 4, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS DISCONNECTS THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT IV TUBING FELL APART WHILE INFUSING. WRITER AT BEDSIDE WHEN INCIDENT OCCURRED. INFUSION IMMEDIATELY STOPPED AND DISCONNECTED FROM PT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21309609 ↗
• MalfunctionJan 6, 2025Contamination; Contamination

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21087444 ↗
• MalfunctionDec 23, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM BD ALARIS PUMP INFUSION SET - DAMAGED TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21009531 ↗
• MalfunctionDec 10, 2024Leak/Splash; Leak/Splash

  MATERIAL#: 2420-0500 , BATCH#: 24083005. IT WAS REPORTED BY THE CUSTOMER THAT ON MIDAZOLAM INFUSION, THE PRIMARY LINE BELOW THE SPIKE, JUST ABOVE THE CLOSED VENT, WAS LEAKING OUT LARGE AMOUNTS OF THE MEDICATION. LOST APPROX 50-60 ML WITHIN MINUTES. RCC RECEIVED A COMPLAINT VIA EMAIL. ON MIDAZOLAM INFUSION, THE PRIMARY LINE BELOW THE SPIKE, JUST ABOVE THE CLOSED VENT, WAS LEAKING OUT LARGE AMOUNTS OF THE MEDICATION. LOST APPROX 50-60 ML WITHIN MINUTES. MANUFACTURER CODE/MODEL: 2420-0500 SERIAL OR LOT NUMBER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894587 ↗
• MalfunctionDec 10, 2024Material Deformation; Material Deformation

  MATERIAL: 2420-0500, BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT THE ALARM WAS SOUNDING AS AN OCCLUSION SO WHEN THE RN GOT TO THE BEDSIDE, THEY OPENED THE PUMP TO FIND THE BUBBLE IN THE TUBING INSIDE. NO INJURY TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892698 ↗
• MalfunctionDec 9, 2024Defective Component; Defective Component

  MATERIAL: 2420-0500. BATCH#: 24083011. IT WAS REPORTED BY THE CUSTOMER THAT THE CHEMO (CYCLOPHOSPHSMIDE) STARTED TO DRIP AND WAS FILLING THE PRIMARY NS I.V. BAG, WHICH WAS LOWER THAN THE CHEMO BAG. RCC RECEIVED A COMPLAINT VIA EMAIL. CHEMO INFUSION WAS ABOUT TO START, THE CHEMO (CYCLOPHOSPHSMIDE) STARTED TO DRIP AND WAS FILLING THE PRIMARY NS I.V. BAG, WHICH WAS LOWER THAN THE CHEMO BAG. THIS SHOULD NEVER HAPPEN AS THE PRIMARY SET WAS THE ALARIS PUMP (LOCKED IN) PRIMARY LINE SET ROLLER WAS ALSO CLAMPED. MANUFACTURER CODE/MODEL: 2420-0500. SERIAL OR LOT NUMBER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20881882 ↗
• MalfunctionDec 2, 2024Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819952 ↗
• MalfunctionNov 22, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET TUBING WOULD NOT CLAMP THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM TYPE OF INCIDENT/PROBLEM: MALFUNCTION - DURING OR AFTER USE LEVEL OF HARM: NO APPARENT HARM - REACHED PATIENT/PERSON AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): YES INCIDENT DETAILS: LINE REMOVED FROM CHANNEL, SAFETY BLUE LOCK DID NOT CLAMP INFUSION STILL RUNNING AND PATIENT RECEIVED FREE FLOWING LEVOPHED. WHO WAS AFFECTED? PATIENT FREQUENCY OF PROBLEM: FIRST TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759025 ↗
• MalfunctionNov 15, 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 IV TUBING CONNECTED AND NOTED TO BE LEAKING. TUBING NOT CONNECTED AT LOWEST HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20699148 ↗
• 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: IT WAS REPORTED BY THE CUSTOMER THAT DEFECTIVENESS OF BD ALARIS PUMP INFUSION SET WAS NOTICED WHEN THE ALARIS INFUSION PUMP STARTED THE INFUSION. SPILL NOTICED AT THE ALARIS CHAMBER SECTION AFTER PUMP WAS CONNECTED TO ALARIS PUMP AND INFUSION WAS STARTED. RN COULD NOT DETERMINE THE POINT OF LEAKAGE ONCE TAKEN OFF THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675507 ↗
• MalfunctionNov 13, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: I RECEIVED FOUR DEFECTIVE ALARIS TUBING SETS FROM OUR AMBULATORY INFUSION CENTER. THEIR REPORT IS THE FOLLOWING: ONE OF THEM HAD A CRACK IN IT AND LEAKED. ONE WAS MISSING THE SPIKE. ONE WAS DAMAGED AT THE ROLLER CLAMP, COULDN'T MOVE THE CLAMP DOWN. ONE WAS DAMAGED UP ABOVE THE FLUID CHAMBER, WAS SMASHED.

  Patient problems: Insufficient Information

  MAUDE report 20674719 ↗
• MalfunctionNov 13, 2024Component Missing; Component Missing

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20674711 ↗
• MalfunctionNov 13, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS DEFECTIVE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: I RECEIVED FOUR DEFECTIVE ALARIS TUBING SETS FROM OUR AMBULATORY INFUSION CENTER. THEIR REPORT IS THE FOLLOWING: ONE OF THEM HAD A CRACK IN IT AND LEAKED. ONE WAS MISSING THE SPIKE. ONE WAS DAMAGED AT THE ROLLER CLAMP, COULDN'T MOVE THE CLAMP DOWN. ONE WAS DAMAGED UP ABOVE THE FLUID CHAMBER, WAS SMASHED.

  Patient problems: Insufficient Information

  MAUDE report 20674706 ↗
• MalfunctionNov 12, 2024Infusion or Flow Problem; Infusion or Flow Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664949 ↗