Alaris, SmartSite 10015861ARecalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 10885403232626), received between May 21, 2019 and Sep 24, 2026 — classified as 80 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (35 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 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889796 ↗
• MalfunctionJul 6, 2026Crack; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD DAMAGED / DEFECTIVE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A THIRD INCIDENT WITH BD TUBING FOR THE ALARIS PRODUCTS. THE FIRST TWO WERE CRACKING BACK IN (B)(6) 2026 AND TODAY (B)(6) 2026. OUR HEMATOLOGY/ONCOLOGY OUTPATIENT TEAM IDENTIFIED DURING A CHEMOTHERAPY INFUSION TO A PATIENT THAT A SMALL PIN HOLE IN THE TUBING WAS SEEN WITH CHEMOTHERAPY DRIPPING OUT OF THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25717235 ↗
• MalfunctionJun 3, 2026Material Deformation

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD A BULGE / BALLOON IN SILICONE SEGMENT / PUMP SEGMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM REPORTING AN INCIDENT WE EXPERIENCED WITH A BD ALARIS PUMP INFUSION SET REF (B)(4). WE ONLY USED ONE TUBING SET. UNFORTUNATELY, WE DO NOT HAVE THE SAVED PACKAGING TO REPORT THE SPECIFIC LOT NUMBER. WE HAVE NARROWED THE LOT DOWN TO EITHER (10)25125451 OR (10)25055230. ADMINISTRATION SET ATTACHED TO BASE SOLUTION BAG AND PRIMED WITH BASE SOLUTION. CHEMOTHERAPY COMPOUNDED APPROPRIATELY. DOSE DELIVERED TO NURSING UNIT VIA TEAM MEMBER HAND-OFF. NURSING ADMINISTERED DOSE VIA APPROPRIATE ALARIS PUMP SET UP PROCEDURES. SEVERAL HOURS AFTER ADMINISTRATION INITIATED PUMP ALARM SOUNDED ALERTING NURSE OF RATE FLOW ERROR. UPON EVALUATION, THE NURSE DISCOVERED BULGING BELOW UPPER PUMP FITMENT IN PUMP SEGMENT LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25381883 ↗
• MalfunctionApr 27, 2026Leak/Splash; Material Integrity Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002569 ↗
• MalfunctionMar 26, 2026Complete Blockage

  IT IS REPORTED, BD ALARIS PUMP INFUSION SET, WHEN LOADED INTO ALARIS PUMP MODULE, MODULES BEEPING OCCLUDED PATIENT SIDE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700335 ↗
• MalfunctionMar 23, 2026Material Integrity Problem

  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 TUBING DEFORMED, UNABLE TO PRIME DUE TO THE HOLE THAT IS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662641 ↗
• MalfunctionMar 10, 2026Material Separation; Air/Gas in Device

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD ALARIS PUMP INFUSION SET (REF (B)(4)) CONTAINING CHEMOTHERAPY CAME APART WHEN USER ATTEMPTED TO DISLODGE AIR BUBBLES FROM LINE (SOFT SECTION THAT IS PLACED INTO THE ALARIS PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559753 ↗
• MalfunctionMar 10, 2026Leak/Splash; Separation Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559408 ↗
• MalfunctionMar 4, 2026Leak/Splash; Material Separation

  SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24514049 ↗
• MalfunctionMar 4, 2026Leak/Splash; Material Separation

  MDR MADE IN ERROR WITH INCORRECT GRID UPDATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508532 ↗
• MalfunctionFeb 24, 2026Fluid/Blood Leak

  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 LEAKAGE WAS OBSERVED NEAR THE PROXIMAL PORT IMMEDIATELY AFTER PRIMING THE TUBING WITH MEDICATION, RESULTING IN MEDICATION LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434801 ↗
• MalfunctionJan 15, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD DAMAGED / DEFECTIVE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS A SMALL PINHOLE LEAK IN THE LOW SORB TUBING RIGHT AROUND WHERE THE HARD PLASTIC COVERING IS LOCATED BELOW ONE OF THE CLAMPS. UNFORTUNATELY, THE SPILL WAS DISCOVERED DURING ADMINISTRATION TO THE PATIENT. THE PATIENT IS FINE. WE HAVE THE BAG IN THE PHARMACY NOW; IT'S FILLED WITH A MEDICATION CALLED KADCYLA. ABOUT 5-10MLS WAS LOST DURING THE SPILL, SO THE BAG IS RELATIVELY FULL WITH DRUG. I CANNOT TELL YOU WHAT THE LOT NUMBER IS UNFORTUNATELY. I CAN ONLY SAY THAT IT IS EITHER LOT (10) 25065355 OR (10)2505502.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24083375 ↗
• MalfunctionDec 16, 2025Backflow; Obstruction of Flow; Backflow; Obstruction of Flow

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT THE SECONDARY MEDICATION OF IRON SUCROSE WITH THE PROPER HEAD HEIGHT OF THE SECONDARY AND PRIMARY BAG LOWER RUNNING 0.9% NORMAL SALINE. CHECK VALVE FAILED ON THE PRIMARY INFUSION LINE ABOUT 1/2 WAY THROUGH INFUSION WITH IRON SUCROSE MIGRATING UP TO THE FLUSH BAG. PRIMARY PUMP INFUSION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824378 ↗
• MalfunctionOct 27, 2025Product Quality Problem; Product Quality Problem

  SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390507 ↗
• MalfunctionOct 27, 2025Leak/Splash; Leak/Splash

  SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389792 ↗
• MalfunctionOct 19, 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 THE DRUG LEAKED FROM THE CONNECTION BETWEEN THE 50ML TEXIUM SYRINGE AND THE PORT ON THE PRIMARY TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23333978 ↗
• MalfunctionOct 15, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING WAS LEAKING BELOW THE Y-SITE. NO ADVERSE EVENTS OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23297228 ↗
• MalfunctionSep 9, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET HAD CONNECTION PROBLEM THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT UPON ATTEMPTING TO HANG MEDICATION, TRAZIMERA, SPIKE OF TUBING BECAME DISCONNECTED FROM MEDICATION BAG, ESTIMATED 100ML OF MEDICATION SPILLED UNTO CHAIR, PUMP, AND FLOOR, AREA CLEANED PER PROTOCOL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001304 ↗
• MalfunctionAug 26, 2025Connection Problem; Connection 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 THE SPIKE FELL OUT OF THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22895664 ↗
• MalfunctionAug 8, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER WAS TRYING TO INFUSE ZENECAR. A PRE-MED TO CHEMO THAT ONLY HAS A 30 MINUTE EXPIRATION TIME. THE DRIP CHAMBER KEPT COLLAPSING ON ITSELF AND NOT ALLOWING THE INFUSION TO FLOW. THE RATE WAS 999.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22759011 ↗
• MalfunctionJul 31, 2025Obstruction of Flow; Obstruction of Flow

  SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22679587 ↗
• MalfunctionJul 21, 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: IT WAS REPORTED BY CUSTOMER THAT THE TUBING BROKE AND SPRAYED CHEMO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22559678 ↗
• MalfunctionJul 14, 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 OBSERVED TUBING HAVE A FINE PINHOLE LEAK FROM WHICH THE TREATMENT WAS LEAKING. UPON FURTHER INSPECTION, THE TREATMENT HAD LEAKED/LEFT A TRAIL FROM THE CHEMO MED ROOM DOWN HALL TO PATIENT'S ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22495667 ↗
• MalfunctionJul 14, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER. IT WAS REPORTED BY THE CUSTOMER THAT FAULTY CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494915 ↗
• MalfunctionJul 14, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER. IT WAS REPORTED BY THE CUSTOMER THAT FAULTY CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494913 ↗