Alaris, SmartSite 10013361Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885403221965), received between Sep 24, 2018 and Oct 12, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT 3 OF THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WERE KINKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING ARRIVES WITH A KINK BELOW THE DRIP CHAMBER THAT PREVENTS FLUIDS FROM MOVING THROUGH. LINES ARE UNABLE TO BE PRIMED. ABOUT 30% OF LOT HAS THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17924846 ↗
• MalfunctionFeb 17, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED WHILE USING BD ALARIS PUMP MODULE SMARTSITE INFUSION SET THE TUBING WAS KINKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE DUE TO TUBING BEING CRIMPED/BENT RIGHT AT THE DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16393987 ↗
• MalfunctionJan 19, 2023Leak/Splash; Deformation Due to Compressive Stress; Leak/Splash; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET TUBING WAS KINKED AND LEAKED DURING USE. THE EVENT OF KINKED TUBING HAPPENED 14 TIMES IN LOT 21125226, AND 4 TIMES IN LOT 21086491. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE SEEING ¿DEFECTIVE¿ INFUSION PUMP SETS. THE TUBING COMING OUT OF THE DRIP CHAMBER IS CRIMPED (BENT) AND IMPEDING THE FLOW OUT OF THE DRIP CHAMBER. WE ARE ALSO SEEING LEAKS IN THE TUBING AT THIS CRIMP AREA AS WELL. IT LOOKS LIKE THIS IS CREATING A WEAK SPOT IN THE TUBING AND FORCING THE SOLUTION PAST THE CRIMPED TUBING IS CAUSING LEAKS. WE ARE USING THIS TUBING FOR CHEMO AND OPTIMA SETS. WAS THERE ANY PATIENT IMPACT/HARM? IF SO WAS THERE A NEED FOR ANY MEDICAL TREATMENT OR INTERVENTION? NO PATIENT HARM, ONE REPORT OF LEAKING OCCURRING AT THE SITE OF THE BENT/CRIMPED TUBING SET THAT DID NOT MAKE IT TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16212516 ↗
• MalfunctionMay 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE TUBING SET SEPARATED AT THE ENGAGEMENT TO THE DRIP CHAMBER WHILE PRIMING THE LINE WITH SALINE.

  Patient problems: No Patient Involvement

  MAUDE report 10082354 ↗
• MalfunctionMay 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE TUBING SET SEPARATED AT THE ENGAGEMENT TO THE DRIP CHAMBER WHILE PRIMING THE LINE WITH SALINE.

  Patient problems: No Patient Involvement

  MAUDE report 10082351 ↗
• MalfunctionApr 3, 2020Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT WHEN PLACING THE TUBING SET INTO THE PUMP MODULE BEFORE STARTING AN INFUSION OF AN INVESTIGATIONAL NON-CHEMOTHERAPY DRUG TO AN ADULT PATIENT, THE TUBING SET SEPARATED AT THE DRIP CHAMBER, AND THERE WAS SPILLAGE OF THE MEDICATION. THE EVENT OCCURRED AT (B)(6). THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT. CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT WHICH STATES, "PT WAS ABOUT TO RECEIVE RESEARCH DRUG (NON-CHEMOTHERAPY) WHILE FIXING TUBING INTO CHAMBER OF PUMP, THE TUBING BROKE IN HALF AND AN UNK AMOUNT OF DRUG SPILLED (PT DID NOT RECEIVE ANY OF THE DRUG) RESEARCH TEAM NOTIFIED, BOTH RESEARCH PHARMACY AND MAIN PHARMACY NOTIFIED FIRST BAG OF RESEARCH DRUG DISPOSED OF PER PHARMACIES ADVICE NEW BAG WAS MIXED AND STARTED FOR PT ABOUT AN HOUR DELAY IN PT¿S OVERALL TREATMENT THE IV LINE CAME APART ABOVE THE PUMP SEGMENT FDA SAFETY REPORT ID# (B)(4)."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9925279 ↗
• MalfunctionAug 9, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING SET SPIKE UNINTENTIONALLY DISCONNECTED FROM THE CHEMOTHERAPY INFUSION BAG CAUSING A SIGNIFICANT LOSS OF MEDICATION. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8881184 ↗
• MalfunctionDec 12, 2018Fluid/Blood Leak; Fluid/Blood Leak

  RECEIVED FROM THE CUSTOMER A COPY OF THE MEDWATCH REPORT WHICH STATES, "PATIENT'S ETOPOSIDE INFUSION LINE LEAKING UNDER PUMP SEGMENT PORTION OF THE TUBING APPROXIMATELY 40 MINUTES INTO THE INFUSION WITH 20 MINUTES REMAINING. INFUSION WAS STOPPED IMMEDIATELY AND A CHEMO SPILL KIT WAS UTILIZED. AN ESTIMATED 321.1 ML SHOULD HAVE BEEN INFUSED WITH 178.9 ML REMAINING . THERE WAS APPROXIMATELY 100 ML OF A SPILL ESTIMATED, ESTIMATING THAT THE PATIENT RECEIVED AROUND 221.1 ML. THE PATIENT WAS REMOVED FROM VICINITY. ETOPOSIDE INFUSION BAG WALKED TO PHARMACY WITH PROPER SAFETY MEASURES TAKEN. MD, PHARMACY, SUPERVISOR NOTIFIED." THERE WAS NO REPORT OF PATIENT HARM. RECEIVED FROM THE FDA A COPY OF THE CUSTOMER'S SUS VOLUNTARY EVENT REPORT WHICH STATES, "PATIENT'S ETOPOSIDE INFUSION LINE LEAKING UNDER PUMP SEGMENT PORTION OF THE TUBING APPROXIMATELY 40 MINUTES INTO THE INFUSION WITH 20 MINUTES REMAINING. INFUSION WAS STOPPED IMMEDIATELY AND A CHEMO SPILL KIT WAS UTILIZED. AN ESTIMATED 321.1 ML SHOULD HAVE BEEN INFUSED WITH 178.9 ML REMAINING . THERE WAS APPROXIMATELY 100 ML OF A SPILL ESTIMATED, ESTIMATING THAT THE PATIENT RECEIVED AROUND 221.1 ML. THE PATIENT WAS REMOVED FROM VICINITY. ETOPOSI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8157794 ↗
• MalfunctionSep 24, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE NURSE INITIATED GEMZAR, A CHEMOTHERAPY INFUSION AND THE TUBING STARTED TO LEAK FROM THE ACCESS PORT. THE INFUSION WAS STOPPED AND THE SPILL WAS CLEANED UP. THERE WAS NO HARM CAUSED TO THE PATIENT FROM THE EVENT, HOWEVER, THE TREATMENT WAS DELAYED DUE TO THE IV FLUID HAVING TO BE REMADE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7902907 ↗