Alaris, SmartSite 2452-0007Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10885403219870), received between May 24, 2019 and Jul 1, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 reports).

1 FDA recall record 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. Jul 8, 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-2180-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Fracture

  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 THE WHITE VALVES BROKE OFF INCLUDING THE BLUE PIECE, CAUSING BUBBLES TO COLLECT IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25686102 ↗
• MalfunctionMay 3, 2026Leak/Splash; Nonstandard Device; Product Quality 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 THE CUSTOMER THAT THE FILTER TUBING THAT WAS USED TO DELIVER THE DRUG ETOPOSIDE HAD A HOLE IN THE BACK OF THE FILTER, WHICH RESULTED IN A LARGE CHEMOTHERAPY SPILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062489 ↗
• MalfunctionJul 21, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS CRACKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT PRIMARY IV TUBING LEAKING ONTO PATIENT. WHEN INSPECTED, A CRACK IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561206 ↗
• MalfunctionJun 3, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS DISCOLORED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING. IT WAS REPORTED BY CUSTOMER THAT DRIP CHAMBER IS BROWN / PLASTIC APPEARS DISTORTED. USUALLY CLEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137718 ↗
• MalfunctionMay 21, 2025Leak/Splash; Separation Failure; Leak/Splash; Separation Failure

  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 WAS FOUND TO BE BROKEN. BLOOD/IV FLUIDS POOLING ON FLOOR FROM BROKEN PORTION OF IV TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062354 ↗
• MalfunctionJul 19, 2024Leak/Splash; Defective Component; Leak/Splash; Defective Component

  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 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CONTRAST ATTACHED TO LOWER Y SITE (OF NS ACCESS LINE) NEAR PATIENT'S HAND. PUMP CHANNEL ALARMED DURING CT SCAN, AND THEN RUBBERIZED PART OF TUBING AUDIBLY "POPPED", SPRAYING NS INTO THE AIR. ONCE SCAN WAS COMPLETE, IT WAS NOTED THAT THERE WAS LEAKAGE ALL OVER THE FLOOR. PATIENT WAS ASSESSED FIRST AND WAS DEEMED STABLE. IT WAS NOTED THAT THE SOURCE OF THE LEAK WAS THE TUBING INSIDE THE PUMP CHANNEL. THE FLOOR WAS STICKY DESPITE THE ACCESS BEING NS, AND THE CT TECHS STATED THAT THE CONTRAST IS STICKY. THE CONTRAST LIKELY WAS PARTIALLY PUMPED BACK UP INTO THE IV PUMP. ACCORDING TO THE TECH, THERE WAS NO NEGATIVE IMPACT TO THE SCANNED IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19785249 ↗
• MalfunctionMar 15, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE IV TUBING IS BROKEN. THE PART OF THE TUBING THAT IS COUPLED TOGETHER WAS NOT CONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16549675 ↗
• MalfunctionJan 18, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET HAD FLOW ISSUES AND WAS UNABLE TO PRIME PAST THE FIRST PORT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AS PER ACCOUNT, IV TUBING UNABLE TO PRIME PAST THE FIRST PORT. IV SOLUTION FILLED THE DRIP CHAMBER AND THE INITIAL PORTION OF TUBING BUT WOULD NOT PROGRESS FURTHER DESPITE ALL CLAMPS BEING OPEN AND PRESSURE BEING APPLIED TO THE BAG."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16191699 ↗
• MalfunctionNov 18, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 100 BD ALARIS PUMP MODULE SMARTSITE INFUSION SETS WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV LINE DOES NOT PRIME PROPERLY. IT PRIMES TO THE DISTAL PORT AND STOPS. DESPITE FLUSHING THE IV SET WITH A SYRINGE WITH SOLUTION IN IT, IT WOULD NOT LET US FLUSH. THESE LINE ARE NOT ABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15828609 ↗
• MalfunctionDec 29, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 BD ALARIS PUMP MODULE SMARTSITE INFUSION SETS HAD COMPONENTS SEPARATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY CUSTOMER THAT THE INFUSION SET WAS LEAKING."

  Patient problems: Insufficient Information

  MAUDE report 13113305 ↗
• MalfunctionJul 1, 2021Free or Unrestricted Flow; Improper Flow or Infusion; Free or Unrestricted Flow; Improper Flow or Infusion

  IT WAS REPORTED THAT THE AS LVP 10D 3SS 2CV INFUSED TOO QUICKLY THROUGH THE SECONDARY INFUSION LINE DUE TO A CHECK VALVE MALFUNCTION, RESULTING IN OVER-INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SECONDARY INFUSION INFUSED FASTER THAN EXPECTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104315 ↗
• MalfunctionMar 23, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT THE AS LVP 10D 3SS 2CV DISTAL PORT WAS BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MOST DISTAL PORT BLOCKED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558609 ↗
• MalfunctionJul 7, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AS LVP 10D 3SS 2CV WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 2452-0007 BATCH #: 19115322. IT WAS REPORTED A BROKEN DISTAL CONNECTION.

  Patient problems: No Patient Involvement

  MAUDE report 10238990 ↗
• MalfunctionJul 7, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AS LVP 10D 3SS 2CV LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 2452-0007 BATCH #: 19107100 IT WAS REPORTED A LEAKAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10238951 ↗
• MalfunctionApr 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE TUBING SET SEPARATED AT THE MIDDLE Y-SITE WHEN PRIMING A 1L NORMAL SALINE BAG. THIS OCCURRED ON 2 NORTH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9944573 ↗
• MalfunctionDec 9, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE SET HAS A HOLE, AND AN UNSPECIFIED FLUID LEAK. THE EVENT OCCURRED IN THE ANESTHESIA DEPARTMENT. IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9438997 ↗
• MalfunctionOct 22, 2019Fluid/Blood Leak; Failure to Prime; Material Puncture/Hole; Fluid/Blood Leak; Failure to Prime; Material Puncture/Hole

  IT WAS REPORTED THAT THE IV TUBING HAS A HOLE IN IT AS IT WOULD NOT PRIME AND KEPT GETTING AIR. THE NURSE FINALLY NOTICED FLUID DRIPPING OUT OF THE TUBING'S FITMENT. THE EVENT OCCURRED DURING PRIMING OF NORMAL SALINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9221944 ↗
• MalfunctionOct 2, 2019Backflow; Backflow

  IT WAS REPORTED THAT IV ANTIBIOTIC PIPERACILLIN-TAZOBACTAM 3.375 GRAMS IN 55ML MINIBAG WAS PROGRAMMED TO INFUSE AT A RATE OF 18.3ML/HR THROUGH IV INFUSION PUMP. IT WAS NOTED THAT THE MEDICATION INFUSED AFTER 30 MINUTES INSTEAD OF 3 HOURS. THE EVENT OCCURRED IN INTENSIVE CARE UNIT (ICU). THERE WAS NO PATIENT HARM. IT WAS NOTED ON A NON-BD INVESTIGATION, THROUGH REVIEW OF DEVICE LOGS AND DISCUSSIONS WITH CLINICAL STAFF, THAT THE EVENT APPEARS TO BE DUE TO A BACKFLOW CHECK VALVE FAILURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9145220 ↗
• MalfunctionSep 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LEAK WAS FROM THE BLUE PLASTIC THAT INSERTS INTO THE PUMP SEGMENT. IT DID NOT APPEAR TO BE CRACKED. IT WAS FURTHER CONFIRMED DURING FOLLOW UP, THAT THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9123607 ↗
• MalfunctionJul 31, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT DURING A SALINE INFUSION ON A CARDIAC PATIENT, THE IV TUBING SEPARATED AT THE TOP OF THE SILICONE SEGMENT AND IV FLUID LEAKED ONTO THE FLOOR. NO PATIENT HARM OCCURRED. NEW TUBING WAS OBTAINED TO CONTINUE THE PATIENT'S INFUSION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8848875 ↗
• MalfunctionJul 31, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT DURING A SALINE INFUSION ON A CARDIAC PATIENT, THE IV TUBING SEPARATED AT THE TOP OF THE SILICONE SEGMENT AND IV FLUID LEAKED ONTO THE FLOOR. NO PATIENT HARM OCCURRED. NEW TUBING WAS OBTAINED TO CONTINUE THE PATIENT'S INFUSION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8848625 ↗
• MalfunctionJul 31, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SALINE INFUSION ON A CARDIAC PATIENT, THE IV TUBING SEPARATED AT THE TOP OF THE SILICONE SEGMENT AND IV FLUID LEAKED ONTO THE FLOOR. NO PATIENT HARM OCCURRED. NEW TUBING WAS OBTAINED TO CONTINUE THE PATIENT'S INFUSION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8847444 ↗
• MalfunctionJul 9, 2019Backflow; Backflow

  IT WAS REPORTED THAT A BACK-CHECK VALVE FAILURE OCCURRED ON THE PRIMARY SET DURING A SECONDARY INFUSION OF PIPERACILLIN/TAZOBACTAM. THE EVENT OCCURRED ON THE SURGICAL CARE UNIT. IT WAS CONFIRMED DURING FOLLOW-UP THAT THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT. RECEIVED A COPY OF THE CUSTOMER'S CMDSNET PROGRAM REPORT FROM HEALTH CANADA, WHICH STATES, "CLINICAL INSTRUCTOR WAS PREPARING A SECONDARY IV MEDICATION (PIP-TAZO) WITH A STUDENT. AFTER PREPARATION THE TUBING WAS INSERTED INTO THE ALARIS PUMP AND THE PRIMARY INFUSION WAS STARTED. THE SECONDARY INFUSION WAS THEN PROGRAMMED AND THE INFUSION START BUTTON WAS INITIATED. THE SECONDARY TUBING CLAMP WAS OPENED AND MEDICATION FROM THE SECONDARY BAG BEGAN BACK-FLUSHING INTO THE NORMAL SALINE BAG THAT WAS BEING USED FOR THE PRIMARY INFUSION. STAFF ON THE UNIT ATTEMPTED TO PROBLEM SOLVE THE ISSUE BUT IT APPEARED TO BE EITHER PUMP OR TUBING RELATED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8773079 ↗
• MalfunctionMay 24, 2019Backflow; Backflow

  THE CUSTOMER REPORTED THAT BACKFLOW OF THE SECONDARY ANTIBIOTIC INTO THE PRIMARY BAG OCCURRED DURING AN INFUSION. THE USER OBSERVED THAT THE DRIP CHAMBER IN THE PRIMARY LINE WAS FILLING UP AND THERE WERE BUBBLES GOING INTO THE PRIMARY BAG. THE CLINICIAN THEN SWITCHED THE SECONDARY LINES AND IT CONTINUED TO BUBBLE INTO THE PRIMARY BAG AND FILL THE DRIP CHAMBER. THE ENTIRE PRIMARY LINE WAS CHANGED AND THE SECONDARY LINE AND THE IV MED BEGAN TO INFUSE PROPERLY. NO PATIENT HARM WAS REPORTED. THE EVENT OCCURRED ON THE SURGICAL INPATIENT UNIT, AND THE DEVICES WERE SENT TO BIOMED WHO TESTED THE PUMPS AND NO FAULT WAS IDENTIFIED. BIOMED ALSO TESTED THE SETS AND CONFIRMED THAT FLUID WAS FLOWING BACKWARDS THROUGH THE CHECK VALVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8639598 ↗