Alaris, SmartSite 10010454Recalls & reported problems

Summary

The FDA's MAUDE database contains 212 adverse event reports that list this exact device (DI 07613203015806), received between Nov 9, 2017 and Jan 29, 2026 — classified as 8 injuries, 204 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (80 reports).

4 FDA recall records name this device's identifier, 3 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. 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 ↗

3. 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 ↗

4. 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 212 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Obstruction of Flow; Air/Gas in Device

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24211301 ↗
• MalfunctionJan 29, 2026Obstruction of Flow; Air/Gas in Device

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24211288 ↗
• MalfunctionDec 13, 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: IT WAS REPORTED BY CUSTOMER THAT THEY CHANGE AADS BAG AND ATTACH TO CURRENT AADS LINE, FOUND THAT TOP OF LINE JUST UNDER SPIKE WAS STICKER WITH OLD YELLOW GOOPY SUBSTANCE, POSSIBLY DUE TO AADS LEAKING FROM EITHER BAG OR LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23798703 ↗
• MalfunctionNov 12, 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: IT WAS REPORTED BY A CUSTOMER THAT THE BLOOD BEGAN TO BACK UP IN TUBING FROM PATIENTS PORT-O-CATH TO FIRST Y-PORT AND SPRAYING ALL OVER FROM Y-PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536803 ↗
• MalfunctionOct 15, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD AIR BUBBLES / AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOMETIMES AIR IN LINE WHEN PRIMING. NURSES ARE TAKING ABOUT 15 MINUTES TO PRIME TUBING, TRYING TO GET AIR OUT OF THE PORTS. THEY ARE TAPPING PORTS AND GETTING STREAMS OF MICROBUBBLES THAT THEY THEN HAVE TO MOVE DOWN THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294022 ↗
• MalfunctionOct 15, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD AIR BUBBLES / AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOMETIMES AIR IN LINE WHEN PRIMING. NURSES ARE TALKING ABOUT 15 MINUTES TO PRIME TUBING, TRYING TO GET AIR OUT OF THE PORTS. THEY ARE TAPPING PORTS AND GETTING STREAMS OF MICROBUBBLES THAT THEY THEN HAVE TO MOVE DOWN THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293963 ↗
• MalfunctionSep 12, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039083 ↗
• MalfunctionSep 12, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038850 ↗
• MalfunctionAug 25, 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 AADS TUBING WAS LEAKING FROM THE DRIP CHAMBER AND THE OUTSIDE OF THE TUBING WAS VERY STICKY AND COATED. IT DID NOT APPEAR THAT THE TUBING HAD INCORRECTLY SPIKED THE AADS BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22887561 ↗
• InjuryAug 25, 2025Infusion or Flow Problem; Infusion or Flow Problem

  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 VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THE ALARIS PUMP WITH A LO-SORBING PE LINED 0.2 MICRON FILTER HAD AN ISSUE WITH THE TUBING, RESULTING IN AN UNEXPECTED INFUSION OF APPROXIMATELY 200ML OF TPN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22886609 ↗
• MalfunctionJul 21, 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 THEY NOTICED MICRON FILTER WAS WET, CLEANED FILTER. MICRON FILTER NOTED TO BE LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22560170 ↗
• MalfunctionJun 27, 2025Material Separation; Separation Problem; Material Separation; 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: IT WAS REPORTED BY CUSTOMER THAT IV LINE WAS DISCONNECTED IN PATIENT BED AT THE LOWER Y - INJECTION SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350226 ↗
• 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 THE 10010454 IS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041222 ↗
• MalfunctionMay 2, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM DESPITE PRIMING WITH NO ISSUE, IV TUBING INFUSING PN WAS RINGING OCCLUDED IMMEDIATELY AFTER CONNECTING TO PATIENT. TROUBLESHOOTING FOUND THAT THERE WAS A SMALL LEAK AT THE FILTER ON THE ALARIS TUBING. TUBING CHANGED AND ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952675 ↗
• MalfunctionMay 2, 2025Leak/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 VERBATIM IT WAS REPORTED BY CUSTOMER THAT IV TUBING INFUSING PN WAS RINGING OCCLUDED IMMEDIATELY AFTER CONNECTING TO PATIENT. TROUBLESHOOTING FOUND THAT THERE WAS A SMALL LEAK AT THE FILTER ON THE ALARIS TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952155 ↗
• MalfunctionMay 1, 2025Leak/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 VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE LEAKS AT THE FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944246 ↗
• MalfunctionApr 2, 2025Leak/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 VERBATIM IT WAS REPORTED BY CUSTOMER THAT LEAKING FROM THE FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751849 ↗
• MalfunctionMar 24, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT UNSPECIFIED BD INFUSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. CURRENTLY A PCU, 2 PUMPS AND A LOW SORBING TUBING PRIMARY IV SET IS SEQUESTERED AT THE HOSPITAL BUT THE ORIGINAL IV BAG WAS DISCARDED. THE BD TEAM EMPHASIZED THE IMPORTANCE OF SENDING THE DEVICES AND TUBING FOR A FORMAL ROOT CAUSE ANALYSIS AT BD. PER THE MANAGER, THE PATIENT WAS A 26-WEEK-OLD PREMATURE BABY ¿ THE PATIENT WAS NOT STABLE PRIOR TO OI EVENT. THE PATIENT CAME IN ON TRANSPORT WITH A PIV INFUSING D10 IN A 500ML IV BAG. ONCE AT THE HOSPITAL THE CLINICIANS ESTABLISHED TWO UMBILICAL LINES AND CHANGED FLUIDS OVER TO THE UMBILICAL LINES. THE PUMPS ARE CHANGED FROM ¿TRANSPORTER¿ PUMPS TO THE PUMPS IN THE ROOM UPON ARRIVAL UNLESS THE SITUATION IS SUPER CRITICAL. TYPICALLY TUBING WOULD NOT BE LEFT HANGING OUTSIDE THE PUMP; THE NURSE WOULD HAVE THROWN AWAY THE D10 IV SET OR TURNED THE CHANNEL OFF AND LEFT THE TUBING IN THE PUMP. BUT, AT THE TIME, THE NURSE CLINICIAN REMOVED THE TUBING FROM THE CHANNEL (BECAUSE THE CHANNEL WAS NEEDED FOR THE FLUIDS ON THE UMBILICAL LINES) BUT THEY LEFT THE TUBING HANGING ON THE IV POLE SO THEY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21684822 ↗
• MalfunctionMar 17, 2025Leak/Splash; Leak/Splash

  IMDRF CODES MUST BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619971 ↗
• MalfunctionFeb 20, 2025Defective Component; Defective Component

  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 VERBATIM IT WAS REPORTED BY CUSTOMER THAT DURING THE LAST 25% OF THE INFUSION, SOLUTION BEGINS TO LEAK FROM THE BACK OF THE FILTER (SIDE OPPOSITE TUBE INLET/OUTLET, FAR END FROM TUBE)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428827 ↗
• MalfunctionFeb 19, 2025Leak/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 VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THERE WERE REPORTS OF LEAKS AT THE FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413197 ↗
• MalfunctionFeb 12, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET HAD FOREIGN MATTER THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT AAD'S LINE TUBING BECAME CLOGGED OVERNIGHT AND SOLUTION UNABLE TO FLOW THROUGH. FILTER HAS BROWN SEDIMENT IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370924 ↗
• MalfunctionFeb 12, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT AAD'S LINE TUBING BECAME CLOGGED OVERNIGHT AND SOLUTION UNABLE TO FLOW THROUGH. FILTER HAS BROWN SEDIMENT IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370799 ↗
• MalfunctionFeb 9, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT AADS ALARMED ON ALARIS PUMP AS "OCCLUDED AT PATIENT SIDE". WRITER ASSESSED PT. CVL WHERE AADS WAS INFUSING AND CVL WAS NOTED TO BE WORKING GOOD AS IT FLUSHED AND BLOOD RETURN WAS OBSERVED BY WRITER. WHEN AADS BAG AND TUBING WAS ASSESSED AND TROUBLESHOOTED, THE SOLUTION DID NOT RUN WITH THE CLAMP OPEN AND THE TUBING DISCONNECTED FROM THE PUMP AND PATIENT. WHEN NEW TUBING WAS PLACED ONTO THE AADS BAG AND PRIMED THE SOLUTION RAN WITH THE CLAMP OPEN AND WAS THEN REATTACHED TO PT AND NO FURTHER PROBLEMS FROM THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21340823 ↗
• MalfunctionFeb 6, 2025Contamination; Contamination

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THEY FOUND A BIG PARTICLE ON TUBING PRIOR TO GET THIS INFUSE TO A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21323673 ↗