Alaris, SmartSite 10015862Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10885403221866), received between Nov 20, 2018 and Feb 20, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24403111 ↗
• MalfunctionFeb 20, 2026Complete Blockage

  IT IS REPORTED OCCLUSION. DESCRIPTION: FOR SOME INFUSIONS (NOT ALL), RNS ARE UNABLE TO GET MEDICATION TO CLEAR FROM DRIP CHAMBER AND TUBING ABOVE PUMP. PUMP IS STATING ¿CONTAINER EMPTY¿ EVEN THOUGH DRUG IS LEFT IN DRIP CHAMBER, AND WHEN RNS PROGRAM EXTRA VOLUME AND PRESS START, PUMP THEN STATES THAT THERE IS AN OCCLUSION. RNS ARE CONCERNED THAT PATIENT IS NOT GETTING THE FULL DOSE OF THEIR MEDICATION. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402243 ↗
• MalfunctionJan 14, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET HAD FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLASTIC SPIRAL PIECE FOUND IN DRIP CHAMBER. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: PLEASE CONFIRM WHETHER THE PLASTIC PIECE IS FOUND BEFORE THE USE OR DURING THE USAGE. THE PLASTIC WAS FOUND ONCE THE FLUID BAG WAS SPIKED BUT BEFORE IT WAS ATTACHED TO THE PATIENT IV. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24069052 ↗
• MalfunctionJan 14, 2026Obstruction of Flow

  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 WE WOULD TRY MULTIPLE LEUR LOCKS AND EVEN TRY ATTACHING A SYRINGE WITHOUT AN ADAPTER AND THE BAG ACCESS PORT WOULD NOT LET ANY FLUID THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068595 ↗
• MalfunctionJan 14, 2026Obstruction of Flow

  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, WE WOULD TRY MULTIPLE LEUR LOCKS AND EVEN TRY ATTACHING A SYRINGE WITHOUT AN ADAPTER AND THE BAG ACCESS PORT WOULD NOT LET ANY FLUID THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068584 ↗
• MalfunctionDec 23, 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 STATE THAT THERE WAS A LEAK IN THE ALARIS TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23880024 ↗
• MalfunctionMay 12, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET WAS KINKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT SECONDARY TUBING WAS KINKED UNDER DROP CHAMBER, UNABLE TO RUN MEDICATION THROUGH PUMP PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005236 ↗
• MalfunctionDec 13, 2024Leak/Splash; Leak/Splash

  MATERIAL# 10015862 AND BATCH# 24095207. IT WAS REPORTED BY CUSTOMER THAT WE JUST HAD ANOTHER FAILED/LEAKING IV SET THAT RESULTED IN A POTENTIAL LOSS OF DRUG DOSE FOR THE PATIENT IN ADDITION TO EXPOSURE OF OUR NURSING STAFF TO HAZARDOUS MEDICATION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE JUST HAD ANOTHER FAILED/LEAKING IV SET THAT RESULTED IN A POTENTIAL LOSS OF DRUG DOSE FOR THE PATIENT IN ADDITION TO EXPOSURE OF OUR NURSING STAFF TO HAZARDOUS MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20921862 ↗
• MalfunctionDec 3, 2024Leak/Splash; Leak/Splash

  MATERIAL # 10015862. BATCH # 24066693. IT WAS REPORTED BY CUSTOMER THAT IN THE LAST WEEK, THEY EXPERIENCED THREE INSTANCES OF FAULTY IV SETS WHERE CYTOTOXIC CHEMO MEDICATION LEAKED FROM THE BAG ACCESS PORT ON THE SIDE OF THE BAG SPIKE. ONE INSTANCE WAS CAUGHT WHEN THE TECHNICIAN HAD JUST FINISHED COMPOUNDING THE MEDICATION AND WAS STILL IN THE IV HOOD. THE OTHER TWO INSTANCES WERE NOTICED WHEN THE IV SET WAS LEAKING FROM THE BAG ACCESS PORT AS THEY WERE ABOUT TO HANG THE MEDICATION FOR THE PATIENT. TO FIX THIS, THEY HAD TO SWITCH THE TUBING ON THESE THREE CHEMO PREPARATIONS BY BRINGING THEM BACK INTO THE IV ROOM. THE FAILED IV SETS WERE REF 10015862 (WHICH FAILED TWICE THIS WEEK) AND 2465-0007 (WHICH FAILED ONCE THIS WEEK). THEY REACHED OUT TO ANOTHER SANFORD SITE, WHICH MENTIONED HAVING HAD THIS ISSUE IN THE PAST AND HAD STARTED USING AN ONGUARD SPIKE ADAPTOR. THEY BEGAN USING THIS ADAPTER TODAY AS WELL BUT STILL EXPERIENCED LEAKAGE FROM THE BAG ACCESS PORT OF THE BD SET (10015862), EVEN THOUGH THAT PORT WAS NEVER UTILIZED DURING COMPOUNDING. RCC RECEIVED A COMPLAINT VIA EMAIL. THE FAILED IV SETS ARE REF 10015862 (OCCURRED TWICE THIS WEEK) AND 2465-0007 (FAILED ONE TIME THIS WEEK)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834164 ↗
• MalfunctionDec 3, 2024Leak/Splash; Leak/Splash

  MATERIAL # 10015862 AND BATCH # 24066693. IT WAS REPORTED BY CUSTOMER THAT IN THE LAST WEEK, THEY EXPERIENCED THREE INSTANCES OF FAULTY IV SETS WHERE CYTOTOXIC CHEMO MEDICATION LEAKED FROM THE BAG ACCESS PORT ON THE SIDE OF THE BAG SPIKE. ONE INSTANCE WAS CAUGHT WHEN THE TECHNICIAN HAD JUST FINISHED COMPOUNDING THE MEDICATION AND WAS STILL IN THE IV HOOD. THE OTHER TWO INSTANCES WERE NOTICED WHEN THE IV SET WAS LEAKING FROM THE BAG ACCESS PORT AS THEY WERE ABOUT TO HANG THE MEDICATION FOR THE PATIENT. TO FIX THIS, THEY HAD TO SWITCH THE TUBING ON THESE THREE CHEMO PREPARATIONS BY BRINGING THEM BACK INTO THE IV ROOM. THE FAILED IV SETS WERE REF (B)(4) (WHICH FAILED TWICE THIS WEEK) AND (B)(4) (WHICH FAILED ONCE THIS WEEK). THEY REACHED OUT TO ANOTHER SANFORD SITE, WHICH MENTIONED HAVING HAD THIS ISSUE IN THE PAST AND HAD STARTED USING AN ONGUARD SPIKE ADAPTOR. THEY BEGAN USING THIS ADAPTER TODAY AS WELL BUT STILL EXPERIENCED LEAKAGE FROM THE BAG ACCESS PORT OF THE BD SET (10015862), EVEN THOUGH THAT PORT WAS NEVER UTILIZED DURING COMPOUNDING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. THE FAILED IV SETS ARE REF (B)(4) (OCCURRED TWICE THIS WEEK) AND (B)(4) (FAILED ONE TIME THIS WE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834140 ↗
• MalfunctionDec 28, 2022Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

  IT WAS REPORTED THAT THE BD ALARIS¿ LVP SS BAG 20D LOW SORB FELL OUT OF THE IV PORT AND EXPOSING NURSES TO DRUG RESIDUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿THIS IS IN REGARD TO 250 ML SODIUM CHLORIDE 0.9% IV BAGS. WE HAVE HAD RECENT INCIDENTS OF BAG SPIKES (ADMINISTRATION SETS FOR BD ALARIS PUMPS) FALLING OUT OF THE IV PORT AND EXPOSING NURSES TO DRUG RESIDUE. NURSES WERE SPLASHED WITH DRUG RESIDUE UPON DIFFERENT INCIDENTS OF DRUG ADMINISTRATION.

  Patient problems: Chemical Exposure

  MAUDE report 16065574 ↗
• MalfunctionApr 21, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED BD ALARIS¿ LVP SS BAG 20D LOW SORB EXPERIENCED UPTICK EVENTS WITH SECONDARY TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHORT SET TUBING WAS NOT PULLING THE MEDICATION FROM THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14173186 ↗
• MalfunctionApr 19, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET EXPERIENCED BLOCKAGE. VERBATIM: WHILE PHARMACY TECHNICIAN WAS USING TUBING 10015862, ALONG WITH BD PHASEAL OPTIMA PRODUCTS, TO CIRCLE PRIME THE LINE. THE DRIP CHAMBER FILLED WITH DRUG, BUT LINE WOULD NOT CIRCLE PRIME. TECHNICIAN USED A SYRINGE TO SYRINGE ADAPTER TO SUCCESSFULLY PRIME THE LINE WITH A SYRINGE, BUT WAS UNABLE TO INJECT THE DRUG INTO THE SMARTSITE BY THE DRIP CHAMBER. THE SMARTSITE WAS BLOCKING ALL FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14142004 ↗
• MalfunctionMay 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TUBING LEAKED DURING AN INFUSION OF CARBOPLATIN (CHEMOTHERAPY).THE LEAK WAS DETECTED IN THE IV TUBING AT THE END PORTION OF THE NON-VENTED DRIP CHAMBER. CHEMO WAS SPILLED ONTO THE FLOOR, PATIENT'S CHAIR, THE IV POLE, AS WELL AS THE PATIENT'S PERSONAL ITEMS. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10099222 ↗
• MalfunctionMay 22, 2020Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT TUBING SET SEPARATED AT THE DRIP CHAMBER AND LEAKED WHILE PRIMING WITH MAGNESIUM SULFATE 6 G (10G/20ML)/150 ML TO INFUSE AT A RATE OF 2 G/HR FOR A DURATION OF 3 HOURS. THERE WAS NO PATIENT INVOLVEMENT SINCE THE SET DID NOT MAKE IT TO THE BEDSIDE.

  Patient problems: No Patient Involvement

  MAUDE report 10083636 ↗
• MalfunctionFeb 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A ALBUMIN-BOUND DOCETAXEL (CHEMOTHERAPY) SPILL THAT WAS INFUSING THROUGH A SHORTER PRIMARY SET ATTACHED TO ANOTHER PRIMARY SET INFUSING 0.9% NORMAL SALINE. THERE WAS POSSIBLE AEROSOLIZED CHEMOTHERAPY EXPOSURE. THE AFFECTED PATIENT, AS WELL AS OTHER PATIENTS AND NURSES, WERE EVACUATED FROM THE INFUSION SUITE PER PROTOCOL. BASED ON THE OBSERVATION OF AMOUNT OF CHEMOTHERAPY ON THE FLOOR, THE TUBING LEAKED AT CONNECTION SITE BETWEEN THE SHORTER TUBING WITH THE OTHER TUBING BELOW THE PUMP. THE LEAK OCCURRED SLOWLY DURING INFUSION. AFTER HAZARDOUS DRUG PRECAUTIONS WERE USED TO CLEAN UP THE SPILL, THE PATIENT REQUIRED A SECOND INFUSION OF CHEMOTHERAPY DUE TO THE DOCTOR NOT KNOWING EXACTLY HOW MUCH THE PATIENT DID NOT RECEIVE. PATIENT WAS DISCHARGED AFTER RECEIVING THE SECOND BAG AND REMAINDER OF PRESCRIBED CHEMOTHERAPY REGIMENT. THERE WERE NO SERIOUS INJURIES CAUSED TO ANY PATIENTS OR NURSES FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 9712489 ↗
• MalfunctionAug 28, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING SET HAD AN UNKNOWN ISSUE.

  Patient problems: No Information

  MAUDE report 8942842 ↗
• MalfunctionAug 9, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT AS THE CARBOPLATIN INFUSION (SECONDARY SET) WAS FINISHING, THE BAG EMPTIED AND THE LAST OF THE DRUG ENTERED THE DRIP CHAMBER. THE DRIP CHAMBER COLLAPSED AND THE BAG WAS SUCKED COMPLETELY DRY. THE PUMP MODULE STARTED TO ALARM AND WOULD NOT INFUSE ANY MORE DRUG WITH MESSAGE "EMPTY CONTAINER/FLUID SIDE". AN ATTEMPT WAS MADE TO INFUSE THE REMAINDER OF THE CHEMOTHERAPY BY GRAVITY, BUT THE PERIPHERAL IV BACK FLOWED DUE TO SUCTION/PRESSURE IN THE LINE AND THE CHEMOTHERAPY DID NOT INFUSE. IT WAS AS IF THE TUBING NEEDED TO BE VENTED, BUT THE SECONDARY SET DID NOT HAVE A VENT. PER PHARMACY, THE PRIMING VOLUME OF THE SET IS LESS THAN 5% OF PATIENT'S TOTAL VOLUME DOSE AND THEREFORE PER PHARMACY, IT WAS OK TO WASTE REMAINING CHEMO IN TUBING AND PROCEED WITH FLUSH OF PRIMARY LINE. THE PRIMARY LINE FLUSHED WITHOUT INCIDENT. 20ML OF THE MEDICATION WAS WASTED, AND IT WAS REPORTED AS UNDER INFUSION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8879038 ↗
• InjuryDec 27, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE TUBING SPIKE WHICH WAS IN A 1000ML BAG OF ETOPOSIDE, DOXORUBICIN, AND VINCRISTINE (VESICANTS) HAD DISLODGED FROM THE BAG AND SPILLED ON THE NURSE. THE SHORT PRIMARY TUBING WAS CONNECTED VERY CLOSE TO THE PUMP. THE NURSE REPORTED THAT SHE FELT AS IF HER SKIN WAS BURNING, SIMILAR TO A SUNBURN, AS A RESULT OF THE CHEMO SPILLING ON HER. THE AREA DID NOT BLISTER AND SHE DID NOT SEE A PHYSICIAN. THE CUSTOMER STATED THAT NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Burning Sensation

  MAUDE report 8199541 ↗
• MalfunctionDec 21, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SECONDARY TUBING SPIKE CAME OUT OF THE 100ML BAG OF AVASTIN (A MONOCLONAL ANTIBODY) AND LEAKED ON THE PATIENT. THE SECONDARY TUBING WAS CONNECTED TO A PRIMARY SET OF A 100ML UNSPECIFIED SOLUTION. THE PATIENT REMOVED HIS SHIRT AND WASHED THE AVASTIN OFF WITH SOAP AND WATER. THERE WAS NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8190038 ↗
• MalfunctionNov 20, 2018Fluid/Blood Leak; Device Dislodged or Dislocated; Fluid/Blood Leak; Device Dislodged or Dislocated

  THE CUSTOMER REPORTED THAT A 1000ML BAG OF 0.9% NS CONTAINING RITUXIN HAD A SPIKE CONNECTION THAT WAS LOOSE AND THE SET DISLODGED FROM THE BAG CAUSING A CHEMO SPILL AFTER THE BAG WAS HUNG ON THE POLE. FLUID SPILLED ON THE PATIENT, HER CLOTHING AND SHOES BUT THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8091707 ↗