Alaris, SmartSite 11171447Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 07613203021234), received between Apr 25, 2018 and Sep 28, 2026 — classified as 3 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (27 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 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Air/Gas in Device

  It was reported that BD alaris smartsite pump infusion set had air in line.The following information was received by the initial reporter with the following Verbatim.It was reported by customer that failure to alarm for air-in-line.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917203 ↗
• MalfunctionMar 19, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT AN ALARIS SMARTSITE BONDED SITE CAME DISCONNECTED; DISTAL END OF TUBING JUST PRIOR TO END OF LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641575 ↗
• MalfunctionFeb 2, 2026Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240335 ↗
• MalfunctionDec 30, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927657 ↗
• MalfunctionDec 17, 2025Complete Blockage; Complete Blockage

  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 CUSTOMER THAT THEY ARE UNABLE TO INJECT THROUGH PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835087 ↗
• MalfunctionNov 23, 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: ONCE 1L BAG OF FLUID WAS SPIKED, THE LINE STARTED LEAKING AT THE BOTTOM OF THE DRIP CHAMBER. DESCRIPTION OF PRODUCT: SET ALARIS 126IN 20 DR 3-Y 2 LUER ST 20EA/CA. LOT OR S/N: (B)(6). INCIDENT DATE: UNKNOWN. COMPLAINT NOTICED: DURING / AFTER USE. PROBLEM FREQUENCY: 1ST TIME. PATIENT INJURY: NO. QTY AFFECTED: 1 EA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23627954 ↗
• MalfunctionNov 21, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THEY UNABLE TO INJECT MEDICATION THROUGH PORT..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619317 ↗
• MalfunctionAug 4, 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 LEAKING FROM THE PLIABLE TUBING PORTION THAT GOES INTO THE ALARIS PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22707240 ↗
• MalfunctionAug 4, 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 LEAKING OCCURRED AT TEXIUM/SMARTSITE PORT CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701771 ↗
• MalfunctionJul 28, 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: LEAKING OCCURRED AT TEXIUM/SMARTSITE PORT CONNECTION. PATIENT AND EMPLOYEES WERE NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628452 ↗
• MalfunctionJul 8, 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 CHEMO FOUND DRIPPING FROM CONNECTION IN THE IV TUBING. ABLE TO RESECURE AND CONTINUE THE INFUSION. THE SECOND EVENT THE NEXT MORNING AT 0800. WITH THIS MEDICATION, AIR BUBBLES ARE VERY COMMON, SO THEY OFTEN HAVE TO REMOVE THE TUBING FROM THE PUMP AND FLICK IT TO MOVE THE BUBBLES UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435391 ↗
• MalfunctionJul 8, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT CHEMO FOUND DRIPPING FROM CONNECTION IN THE IV TUBING. ABLE TO RESECURE AND CONTINUE THE INFUSION. THE SECOND EVENT THE NEXT MORNING AT 0800. WITH THIS MEDICATION, AIR BUBBLES ARE VERY COMMON, SO THEY OFTEN HAVE TO REMOVE THE TUBING FROM THE PUMP AND FLICK IT TO MOVE THE BUBBLES UP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435389 ↗
• MalfunctionJun 30, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING OCCURRED AT TEXIUM/SMARTSITE PORT CONNECTION. PATIENT AND EMPLOYEES WERE NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22364973 ↗
• MalfunctionJun 3, 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 CHEMO RN CAME TO THE PHARMACY STATING WHEN INFUSION WAS STARTED ON HER KEYTRUDA 400MG PIGGYBACK DROPS OF FLUID BEGAN TO LEAK WHERE TEXIUM MET PATIENT LINE (ATTACHED WITH ARROW POINTING TO AREA OF INTEREST).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22133959 ↗
• MalfunctionMay 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CHEMO RN CAME TO THE PHARMACY STATING KEYTRUDA IV PIGGYBACK LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081616 ↗
• 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 WHILE PRIMING THE LINE THE NURSE NOTED THAT THERE WAS QUITE A BIT OF LEAKAGE FROM THE SITE WHERE THE SECONDARY TUBING MEETS THE PRIMARY TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041242 ↗
• MalfunctionMay 13, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS TEXIUM SMARTSITE LOW SORBING SECONDARY SET WAS LOOSE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. CHEMO RN CAME TO THE PHARMACY STATING WHEN INFUSION WAS STARTED ON HER ZIRABEV PIGGYBACK DROPS OF FLUID BEGAN TO LEAK WHERE TEXIUM MET PATIENT LINE (ATTACHED WITH ARROW POINTING TO AREA OF INTEREST). RN STOPPED INFUSION AND TRIED RE-TIGHTENING CONNECTION. WHEN INFUSION WAS STARTED AGAIN FLUID BEGAN TO LEAK FROM CONNECTION SEAM OF TEXIUM AND PATIENT LINE AGAIN. MEDICATION, LINES, AND ORIGINAL PACKAGING WERE PLACED INTO CHEMOTHERAPY HAZARD BAG AND SENT TO THE PHARMACY. PHARMACY TECHS SUPPLIED ORIGINAL PACKAGING USED FOR CHEMO PIGGY BACK AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22012830 ↗
• MalfunctionMay 6, 2025Leak/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. IT WAS REPORTED BY CUSTOMER THAT THE LEAKAGE AT THE TEXIUM TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972979 ↗
• MalfunctionMay 6, 2025Leak/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: IT WAS REPORTED BY CUSTOMER THAT THE LEAKAGE IS AT THE TEXIUM TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972962 ↗
• MalfunctionApr 23, 2025Leak/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 IT WAS REPORTED BY THE CUSTOMER THAT NOTICED SEVERAL IV TUBING SETS LEAKING BELOW THE DRIP CAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896596 ↗
• MalfunctionApr 4, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE PATIENT RECEIVED APPROX.. 300ML OF FLUID (3KG PATIENT), RESULTING IN FLUID OVERLOAD. THE PATIENT REQUIRED ADDITIONAL MEDICATIONS AND SUPPORTS TO MANAGE THE FLUID. IT IS UNKNOWN WHAT THE LONG-TERM EFFECTS ARE FOR THE PATIENT AS THE PATIENT HAS OTHER MEDICAL COMPLEXITIES THAT THEY ARE ALSO MANAGING. NO ADDITIONAL INFORMATION PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775384 ↗
• MalfunctionMar 21, 2025Disconnection; Disconnection

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668201 ↗
• MalfunctionMar 17, 2025Material Deformation; Material Deformation

  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 (B)(6) 2025 PATIENT HERE FOR TAXOL, HERCEPTIN, 3RD TREATMENT. PIV WAS PLACED IN PATIENTS L HAND. PAPER TAPE WAS APPLIED TO THE CSTD AND AT THE PIV SITE. ABOUT HALF WAY THROUGH THE 3-HOUR TAXOL, PATIENT HAD TO USE THE BATHROOM. WHEN PATIENT CAME BACK FROM THE BATHROOM, BEFORE SITTING DOWN, THE RN CHECKED THE PIV SITE AND CONNECTION. EVERYTHING LOOKED GOOD. RIGHT AFTER THE PATIENT SAT DOWN, THE RN NOTED DROPS OF FLUID COMING FROM THE CONNECTION (N35-0) TO REGULAR TUBING. CHEMOTHERAPY DID NOT GET ON THE PATIENT. IT FELL TO THE FLOOR. APPROXIMATELY LESS THAN 5 ML WERE SPILLED. RN NOTED THAT THE TUBING WAS KINKED JUST AFTER THE HARD PLASTIC CONNECTION SITE. RN RECONNECTED THE TUBING AND APPLIED A 3RD PIECE OF TAPE ABOVE, ON THE PATIENT¿S DRESSING TO PREVENT FURTHER KINKING. RN NOTIFIED PHARMACY AND PHYSICIAN. NO NEW ORDERS GIVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617545 ↗
• MalfunctionMar 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS KINKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT THE RN NOTED DROPS OF FLUID COMING FROM THE CONNECTION (N35-0) TO REGULAR TUBING. CHEMOTHERAPY DID NOT GET ON THE PATIENT. IT FELL TO THE FLOOR. APPROXIMATELY LESS THAN 5 ML WERE SPILLED. RN NOTED THAT THE TUBING WAS KINKED JUST AFTER THE HARD PLASTIC CONNECTION SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617515 ↗
• MalfunctionFeb 19, 2025Leak/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 "WHILE TITRATING PT'S RITUXIMAB WRITE NOTICED THAT WHEN THE RATE WAS BUMPED UP THE DRUG WAS DRIPPING FROM ALARIS CHANNEL. TUBING SHOWED A PIN HOLE LEAK NEAR CONNECTION FOR PUMP. NOT MUCH DRUG WAS LOST AND LYM TEAM MADE AWARE AND INSTRUCTED TO CHANGE PRIMARY TUBING AND PROCEED WITH TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413147 ↗