Alaris, SmartSite 10013072Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 07613203021210), received between Jul 31, 2018 and Sep 20, 2023 — classified as 1 injury, 32 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (15 reports).

3 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. Apr 18, 2024Class IIOpen, Classified

   Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.

   Z-1944-2024 · Root cause: Process control · 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2023Defective Component; Defective Component

  THE CUSTOMER ORIGINALLY REPORTED AN ISSUE WITH A 2420-0007 MATERIAL (NO LOT), BUT RETURNED TWO SAMPLES JUST FROM THE DRIP CHAMBER UP, NO OTHER TUBING. THE RETURN ALSO INCLUDED THE LABEL FOR THE MATERIAL, WHICH WAS OF MATERIAL 10013072 AND LOT 22115368. THE REPORTED MATERIAL WAS UPDATED TO 10013072 BASED ON THE SAMPLES THAT WERE SUBMITTED. THIS INVESTIGATION IS FOR MATERIAL 10013072 LOT 22115368. VERBATIM FROM CUSTOMER: RCC RECEIVED COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ISSUE DESCRIPTION QUALITY ISSUE ¿ BROKEN (OUT OF BOX) NO PATIENT OR USER INJURY REPORTED. RN WAS PLACING THE LINE IN THE ALARIS PUMP THE LINE SNAPPED BELOW CHAMBER- LUCKILY LINE WAS JUST FILED WITH NORMAL SALINE. THE SECOND SAMPLE WAS WHEN RN WAS TRYING TO SWITCH FROM N/S BAG TO CHEMO BAG BEFORE CONNECTING TO CHEMO -LINE SNAPPED BELOW CHAMBER. OCCURRENCES 2. SAMPLES AVAILABLE YES, QUANTITY: 2. MON (B)(6) 2023 3:47 PM. COULD YOU PLEASE PROVIDE BATCH NUMBER? REF#(B)(4) AND LOT #(10)230055525.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17786026 ↗
• MalfunctionAug 7, 2023Break; Break

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17475423 ↗
• MalfunctionAug 7, 2023Improper Flow or Infusion; Improper Flow or Infusion

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17475409 ↗
• MalfunctionJul 24, 2023Break; Break

  IT WAS REPORTED THAT WHILE USING THE BD ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS THE LINE BROKE FROM BELOW THE DRIP CHAMBER. THE FOLLOWING WAS RECIEVED FROM THE INITIAL REPORTER: VERBATIM: CUSTOMER REPORTED OCCURRED DURING PATIENT USE (WITHIN 5-10 MINUTES OF TREATMENT) ¿ NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION. LINE WAS PRIMED WITH NORMAL SALINE AS RN WAS TRYING TO START CHEMO-BEFORE STARTING-THE LINE BROKE FROM BELOW DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17385989 ↗
• MalfunctionJul 19, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING USE WITH BD ALARIS¿ LVP 20D LOW SORB 2SS CV THE TUBING SET SEPARATED BELOW THE DRIP CHAMBER. THIS IS THE 4TH OF 4 INSTANCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THEY HAVE HAD 4 TUBING SET FAILURES WITH THE ATTACHED BD OPTIMA CSTD IN THE ONCOLOGY INFUSION CENTER. (B)(6) 2023 BD ALARIS PUMP INFUSION SET LOW SORBING TUBING (PE LINED) BACK CHECK VALVE, TWO SMARTSITE Y-SITES: REF: 10013072. LOT: (10)22115368 EXP: 2025-11-17. DOCETAXEL. BELOW DRIP CHAMBER FAILURE ¿ TUBING BOND FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17350216 ↗
• MalfunctionJul 19, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING USE WITH BD ALARIS¿ LVP 20D LOW SORB 2SS CV THE TUBING SET SEPARATED BELOW THE DRIP CHAMBER. THIS IS THE 3RD OF 4 INSTANCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THEY HAVE HAD 4 TUBING SET FAILURES WITH THE ATTACHED BD OPTIMA CSTD IN THE ONCOLOGY INFUSION CENTER. 5/18/23 BD ALARIS PUMP INFUSION SET LOW SORBING TUBING (PE LINED) BACK CHECK VALVE, TWO SMARTSITE Y-SITES: REF: 10013072. LOT: (10)22115368. EXP: 2025-11-17. DOCETAXEL. BELOW DRIP CHAMBER FAILURE ¿ TUBING BOND FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17350215 ↗
• MalfunctionJun 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT 2 BD ALARIS¿ PUMP MODULE SMARTSITE¿ LOW SORBING INFUSION SETS' TUBING DETACHED FROM THE DRIP CHAMBER WHILE PREPARING THEM FOR USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DRIP CHAMBER DETACHED FROM TUBING WHILE LINE WAS PREPPED FOR CHEMO USE WHO WAS AFFECTED? NO PERSON AFFECTED UNEXPECTED OR PROLONGED CARE? NO".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075940 ↗
• MalfunctionJun 2, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ LOW SORBING INFUSION SET TUBING DETACHED FROM THE DRIP CHAMBER WHILE PREPARING IT FOR USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DRIP CHAMBER DETACHED FROM TUBING WHILE PREPPING FOR USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049143 ↗
• MalfunctionMay 15, 2023Break; Break

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ LOW SORBING INFUSION SET TUBING BROKE APART. THIS OCCURRED WITH 3 SETS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CALLER STATES THE TUBING IS BREAKING APART."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928452 ↗
• MalfunctionApr 16, 2023Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ LOW SORBING INFUSION SET TUBING BROKE APART IN THE DRIP CHAMBER AND LEAKED OUT ETOPOSIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE TUBING BROKE APART IN THE DRIP CHAMBER. NO PATIENT IMPACT NO ADVERSE EFFECT. DID YOU ENCOUNTER ANY LEAKAGE DURING THE INCIDENT? YES WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? YES, AFTER CLEANUP PRODUCT NEEDED TO BE REMADE. WHAT TYPE OF PROCEDURE IS BEING PERFORMED? INFUSION. WHAT MEDICATION WAS USED? ETOPOSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748692 ↗
• MalfunctionNov 4, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ INFUSION SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BLUE PLASTIC PIECE THAT SITS ABOVE WHERE THE TUBING IS INSERTED INTO THE PUP WAS DRIPPING THE CHEMO. I HAD A RN TELL ME THAT SHE RECENTLY HAD AN ISSUE WHEN SHE OPENED THE TUBING, THAT IT APPEARED TO BE DRY ROTTED. I WAS NOT MADE AWARE WHEN SHE NOTICED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752026 ↗
• MalfunctionMar 23, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE TUBING SECTION THAT GOES IN THE PUMP HAD A SMALL HOLE THAT LEAKED WHILE INFUSING CYCLOSPORINE ON THE BMT (BONE MARROW TRANSPLANT) UNIT. THE INFUSION OF CYCLOSPORINE WAS RUNNING AT 126 ML/HOUR AS A SECONDARY INFUSION. NO PATIENT HARM OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9868100 ↗
• MalfunctionFeb 6, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE IV TUBING SET LEAKED BETWEEN THE MALE LUER AND THE BAXTER FILTER DURING AN EPOCH INFUSION AT A RATE OF 20.8 ML FOR 6 HOURS. THERE WAS NO PATIENT IMPACT.

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

  MAUDE report 9674901 ↗
• MalfunctionJan 8, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT (PACLITAXEL ) WAS INFUSING DURING CIRCLE PRIMING AND THE NURSE NOTICED THAT CHEMOTHERAPY WAS COMING OUT FROM THE IN-LINE FILTER. THE TUBING GOT WET ON THE OUTSIDE AND NURSE WAS TOUCHING THE TUBING WITH GLOVES ON. THE NURSE WAS EXPOSED TO THE (PACLITAXEL) CHEMOTHERAPY. THERE WERE NO INTERVENTIONS NEEDED FOR THE NURSE. APPROPRIATE PROTECTIVE EQUIPMENT WAS USED (CHEMO GLOVES).NO EXPOSURE TO THE PATIENT WAS REPORTED. BECAUSE THERE WAS DRUG IN THE TUBING WE HAD TO DISCARD THE ENTIRE SET UP. THE BAG OF CHEMOTHERAPY WAS DISCARDED AND A NEW ONE HAD TO BE PREPARED. THERE WAS A DELAY IN ADMINISTRATION OF DRUG.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9564227 ↗
• MalfunctionDec 5, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE IV PUMP ALARMED INFUSION COMPLETE FOR CHEMOTHERAPY TAXOL WITH TOTAL VOLUME OF 595ML. IT WAS NOTED THAT THE INTENDED RATE OF INFUSION WAS 180-190ML/HR AND WAS PROGRAMMED USING GUARDRAILS DRUG LIBRARY. WHEN THE NURSE ATTENDED TO THE PATIENT, IT WAS FOUND THAT 100ML OF THE MEDICATION WAS STILL LEFT IN THE BAG. THE REMAINING VOLUME WAS EVENTUALLY INFUSED UNTIL THE BAG WAS DRY. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9417910 ↗
• MalfunctionNov 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AND INFUSION, AN INVESTIGATIONAL MEDICATION WAS MIXED IN 100 ML OF NORMAL SALINE AND SCHEDULED TO BE ADMINISTERED AT A RATE OF 50 ML/HR. THE INFUSION STARTED AT 15:30 AND ENDED AT 15:50, TWENTY MINUTES LATER. ALL INSPECTIONS PRIOR TO THE START OF THE ADMINISTRATION DID NOT DETECT ANY LIQUID LEAKING FROM THE TUBING, HOWEVER; THE NURSE NOTICED A POOL OF LIQUID UNDER THE INFUSION PUMP AND LIQUID DRIPPING FROM THE BOTTOM OF THE PUMP. THE PHARMACIST INSPECTED THE ADMINISTRATION SET AND NOTED THAT THE TUBING CONNECTION TO THE IV WAS INTACT AND THAT THE TUBING SPIKE HAD NOT PENETRATED THE IV BAG NECK. THE REMAINDER OF THE ADMINISTRATION SET APPEARED TO BE INTACT, EXCEPT FOR THE AREA AROUND THE INFUSION PUMP CONNECTION. THIS INCIDENT OCCURRED IN THE CTU INFUSION SUITE OF THE CANCER CENTER. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9351021 ↗
• MalfunctionNov 14, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN INFUSION, THE RN WAS ATTEMPTING TO HANG ETOPOSIDE AS THE PRIMARY INFUSION WHEN IT WAS NOTICED THAT THE OUTSIDE OF THE FILTER WAS FULL OF AIR AND WET. IT WAS 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 9322881 ↗
• MalfunctionOct 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TUBING HAD A VISABLE HOLE AND FLUID LEAK FROM TUBING JUST BELOW THE DRIP CHAMBER. NO PERSON WAS AFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9189427 ↗
• MalfunctionSep 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  RECEIVED A COPY OF THE CUSTOMER'S CMDSNET PROGRAM REPORT FROM HEALTH CANADA WHICH STATES, ¿LEAK AT BACK CHECK VALVE - PRODUCT DID NOT REACH THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9123640 ↗
• MalfunctionJul 30, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT AFTER A PRIMARY INFUSION OF ETOPOSIDE 110MG/5.5ML AT A RATE OF 542ML/HR HAD COMPLETED, THERE WAS 70ML OF CHEMOTHERAPY REMAINING IN THE BAG. THE TOTAL VOLUME WAS 545.2ML. THE CUSTOMER STATES THAT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8844259 ↗
• MalfunctionJun 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A SECONDARY EPOCH INFUSION THE USER NOTICED THAT THERE WAS A LEAK IN THE SILICONE SEGMENT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM WHEN THE CHEMO LEAK (50ML) OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8709745 ↗
• MalfunctionJun 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A SECONDARY EPOCH INFUSION THE USER NOTICED THAT THERE WAS A LEAK IN THE SILICONE SEGMENT. THE CUSTOMER CONFIRM THAT THERE WAS NO PATIENT HARM WHEN THE CHEMO LEAK (50ML) OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8709512 ↗
• MalfunctionApr 10, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE RN ACTIVATED THE ROLLER CLAMP AND NOTICED THAT SALINE WAS FLOWING OUT OF THE LOWEST Y-SITE PORT. WHEN CONNECTED TO PATIENT IV CATHLON. THERE WAS NO REPORTED PATIENT HARM PER CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8501904 ↗
• MalfunctionFeb 25, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE CUSTOMER REPORTED THAT ON THE 4TH FLOOR CHEMOTHERAPY UNIT, THE RN PRIMED THE TUBING SET PER THEIR POLICY WITH LEUCOVORIN WITHOUT DIFFICULTY. ONCE PRIMED, THE NURSE ATTACHED THE TUBING TO THE PATIENT AND PLACED THE TUBING SET INTO THE ALARIS PUMP PER FACILITY PROTOCOL. AFTER THE PUMP DOOR WAS CLOSED THE TUBING SEPARATED BELOW THE BLUE SAFETY CLAMP AND LEAKED A SMALL AMOUNT OF LEUCOVORIN ONTO THE USER'S CHEMOTHERAPY GOWN AND THE FLOOR, BUT NOT THE PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8366818 ↗
• InjuryFeb 22, 2019Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE TUBING SET SEPARATED DURING A RITUXIMAB 750MG/NS 270ML (WITH 20ML OVERFILL) INFUSING AT A RATE OF 23ML/HOUR (50MG/HOUR) WITH A TOTAL VTBI OF 345ML. ALTHOUGH THERE WAS NO PATIENT HARM, THERE WAS A SLIGHT DELAY IN TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8360764 ↗