Alaris, SmartSite 24600-0007Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10885403241970), received between Dec 2, 2020 and Jul 23, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (13 reports).

2 FDA recall records name this device's identifier, 2 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. Oct 11, 2023Class IIOpen, Classified

   Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

   Z-0349-2024 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2025Backflow; Backflow

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD BLOOD BACKFLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE IV TUBING HAD BLOOD BACKED UP HALF THE LENGTH OF THE TUBING ALTHOUGH IT WAS STILL INFUSING. WHEN I CHECKED THE LINE I FOUND THAT THE CHEMO BAG (CYTARABINE) WAS INFUSED AND THAT ROUGHLY HALF OF THE PRIMARY BAG HAVING BEEN INFUSED AS WELL, ALMOST AS IF THE PUMP WAS PULLING FROM BOTH LINES. THIS WAS NEAR THE TAIL END OF THE INFUSION WITH ONLY 30 MLS APPROX REMAINING. BY THE TIME I CAME BACK TO TAKE THE LINE DOWN THE REMAINDER OF THE BLOOD IN THE TUBING HAD REINFUSED INTO THE PATIENT. AT THE TIME THE PT SAID THEY HAD ONLY BEEN TO THE BATHROOM. THERE WAS NO LEAKAGE PRESENT AROUND THE PATIENT AREA NOR DID THE PATIENT SAY THE LINE READ ANY ERROR WHILE I WAS ON BREAK. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY? 06-13-2025 DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO NEGATIVE OUTCOME TO THE PATIENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575974 ↗
• MalfunctionJul 3, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS SMART SITE 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 TUBING ARRIVED TO UNIT BROKEN IN HALF AT Y-SITE NEAR ROLLER CLAMP WITH TUBING PRIMED WITH MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401261 ↗
• MalfunctionJan 16, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172530 ↗
• MalfunctionOct 16, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT REGARDING THE LOW SORB TUBING LEAKING DURING A TACROLIMUS PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461444 ↗
• MalfunctionOct 16, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461304 ↗
• MalfunctionAug 8, 2024Leak/Splash; Defective Component; Leak/Splash; Defective Component

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: WE HAD AN INCIDENT TODAY AT LMH INVOLVING A CHEMOTHERAPY SPILL. IT IS SUSPECTED THAT IT OCCURRED AS A RESULT OF A FAULTY IV SET (REF24600-0007). WE HAVE KEPT THE SET SO THAT WE CAN SEND IT BACK FOR INVESTIGATION; HOWEVER, IT STILL HAS AN EMPTY BAG OF CHEMOTHERAPY ATTACHED TO IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19945098 ↗
• MalfunctionDec 1, 2023Leak/Splash; Defective Component; Leak/Splash; Defective Component

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18246342 ↗
• MalfunctionNov 30, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: WHILE PRIMING LARONIDASE, FLUID BEGAN SPRAYING FORM TUBING. MEDICATION SPRAYED ON RN AND SURROUNDING ENVIRONMENT. HOLE FOUND AND PRESSURE APPLIED - AREA TAPED AND TUBING BAGGED TO SEND TO CENTRAL. PHARMACIST CALLED RN TO REQUEST EMAIL EXPLAINING EQUIPMENT MALFUNCTION IN ORDER TO MAKE ANOTHER DOSE OF THIS ENZYME MEDICATION. EMAIL SENT AND SAFETY REPORT COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 18240411 ↗
• MalfunctionMar 29, 2023Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ LOW SORBING INFUSION SET TUBING BROKE AND LEAKED OUT CHEMO MEDICATION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WANTED TO BRING UP AN ISSUE REGARDING CHEMO TUBING. A NURSE WAS SPLASHED WITH CHEMO WHEN IV TUBING BROKE. SHE MENTIONED THIS IS NOT THE FIRST TIME IT HAS BROKEN UNEXPECTEDLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635630 ↗
• MalfunctionMar 24, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ LOW SORBING INFUSION SET IV TUBING BROKE AND SPLASHED THE NURSE WITH CHEMOTHERAPY MEDICINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WANTED TO BRING UP AN ISSUE REGARDING CHEMO TUBING. A NURSE WAS SPLASHED WITH CHEMO WHEN IV TUBING BROKE. SHE MENTIONED THIS IS NOT THE FIRST TIME IT HAS BROKEN UNEXPECTEDLY."

  Patient problems: Chemical Exposure

  MAUDE report 16610925 ↗
• MalfunctionFeb 15, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT 1 BD ALARIS¿ PUMP MODULE SMARTSITE¿ LOW SORBING INFUSION SET EACH FROM LOTS 22085259 AND 22085260 HAD SLITS IN THEIR TUBING THAT CAUSED LEAKAGE DURING THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD AN IV SET LEAK TOWARDS THE END OF A 550ML INFUSION. THE LEAK DEVELOPED AT THE JUNCTION WHERE THE DARK BLUE PLASTIC MEETS THE SOFT RUBBER TUBING ON THE PRIMARY SET (THIS IS THE PART OF THE LINE THAT GETS PLACED ON THE ALARIS PUMP MODULE). I INSPECTED THE LINE CLOSELY AND IT APPEARS THAT THERE WAS A SLIT ON THAT SPOT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16382754 ↗
• MalfunctionNov 30, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SETS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAK WAS DISCOVERED DURING INFUSION AT THE Y-SITE PORT CLOSEST TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15890719 ↗
• MalfunctionJan 28, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHORTLY AFTER NURSE (B)(6) CHEMO, PATIENT CALLED OUT AND STATED THAT SOMETHING WAS LEAKING. INFUSION STOPPED. CHEMO INFUSION SET NOTED TO BE LEAKING FROM EXTENSION PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13386102 ↗
• MalfunctionNov 23, 2021Backflow; Backflow

  IT WAS REPORTED THAT WHILE USING BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET THAT FLOW ISSUES AND CHECK VALVE MALFUNCTION OCCURRED 1 TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SECONDARY LINE BACK-FLUSHED. FLUID WAS FREE-FLOWING BACK INTO PRIMARY BAG. UNKNOWN AMOUNT OF CHEMO DRUG LOST TO PRIMARY BAG. ENTIRE LINE DISCONNECTED FROM PATIENT. NEW NON-DEHP LINE PRIMED AND ATTACHED TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865951 ↗
• MalfunctionNov 11, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ LOW SORBING INFUSION SET HAD FLOW ISSUES DURING THE DOCETAXEL INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DOCETAXEL BAG WITH ATTACHED SECONDARY LINE CONNECTED TO PRIMARY NON-DEHP LINE. SECONDARY LINE BACK-FLUSHED TO CLEAR AIR. ONCE SECONDARY BAG (DOCETAXEL) HUNG HIGHER TO PRIMARY BAG WRITER NOTICED THAT DOCETAXEL FLUID WAS FREE-FLOWING BACK INTO PRIMARY BAG . PRIMARY BAG CHAMBER FILLED AND POSSIBLY FILLED INTO THE PRIMARY BAG. UNKNOWN AMOUNT OF CHEMO DRUG LOST TO PRIMARY BAG. WRITER NOTED THAT THE NON-DEHP LINE DID NOT HAVE A BACK CHECK VALVE. ENTIRE LINE DISCONNECTED FROM PATIENT. NEW NON-DEHP LINE PRIMED AND ATTACHED TO PATIENT. DOCETAXEL REMIXED BY PHARMACY AND INFUSION COMMENCED WITHOUT FURTHER ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800981 ↗
• MalfunctionJul 17, 2021Leak/Splash; Free or Unrestricted Flow; Leak/Splash; Free or Unrestricted Flow

  IT WAS REPORTED THAT ALS SET DC 20DP 3SS CKVLV LOW SRB DEHP F EXPERIENCED AN AIR IN LINE ALARM DURING USE, AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A TUBING MALFUNCTION (6/18) ON OUR ONCOLOGY UNIT. THEY REMOVED FROM PUMP TO PURGE WITH ¿AIR IN LINE ALARM¿ AND IT STARTED LEAKING AT THE PUMP SECTION TUBING AND THAT BLUE CONNECTOR PIECE ABOVE THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186156 ↗
• MalfunctionJun 16, 2021Leak/Splash; Unintended Movement; Leak/Splash; Unintended Movement

  IT WAS REPORTED THAT THE AS LVP 20D LOW SORB 3SS CV TUBING SEPARATED FROM THE ICU MEDICAL SPIROS DURING USE. ADDITIONALLY, IT WAS REPORTED THAT THE CLAMP ON THE TUBING MOVED TOO EASILY AND CAUSED FLUID REFLUX. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NURSES PROVIDED FEEDBACK REGARDING TUBING NOT WORKING REALLY WELL WHEN CONNECTED TO BD ALARIS TUBING; NOTING TUBING DOES NOT APPEAR TO BE USER FRIENDLY, STOPCOCK ON TUBING BEING SENSITIVE WITH OCCASIONAL FLUID REFLUX BACK INTO CARRIER FLUID TUBING NOTED"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12013324 ↗
• MalfunctionJan 6, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE AS LVP 20D LOW SORB 3SS CV HAD FLOW ISSUES WHEN INFUSING TAXOL, LEAVING "140 CC" LEFT IN THE BAG. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS WAS AN UNDER INFUSION INCIDENT- ONCE CHEMO (TAXOL) INFUSION WAS COMPLETED THERE WAS STILL 140 CC LEFT OVER OF CHEMO IN THE BAG. (TOTAL VOLUME 608CC)"

  Patient problems: Insufficient Information; Underdose

  MAUDE report 11128898 ↗
• MalfunctionDec 2, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE AS LVP 20D 1.2M WAS BLOCKED/OCCLUDED DURING USE AND THE NURSE COULD NOT PULL FLUID THROUGH WITH A SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD ALARIS PUMP TUBING WITH INLINE 1.2 MICRON FILTER CLOGGED WITH INTRALIPID FAT EMULSION. LIPIDS HAD BEEN RUNNING FOR APPROXIMATELY 16 HOURS. AFTER REMOVAL, RN ATTEMPTED TO PULL FLUID THROUGH WITH A SYRINGE AND WAS UNABLE TO DESPITE MAXIMAL FORCE. 24 HOURS LATER, THIS SUBMITTER WAS ABLE TO ATTACH A STOPCOCK AND PULL FLUID THROUGH THE FILTER WITH NO ISSUES, ALTHOUGH DID FEEL TO BE HIGHER THAN EXPECTED RESISTANCE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10935718 ↗