Alaris, SmartSite 20350ERecalls & reported problems
BD Switzerland Sàrl · Low Sorbing Extension Set, 0.2 Micron Low Protein Binding Filter Needle-Free Valve 43 cm (17 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Alaris SmartSite extension set has 168 reports, with no deaths and no injuries. Many reports describe the filter leaking, cracking, or separating from the tubing, and some describe blocked flow. Most list no clinical signs in the patient. No recalls name this device, and reports rose from 10 in the prior 12 months to 38 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 170
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 07613203012256), received between Aug 28, 2018 and Sep 18, 2026 — classified as 170 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (45 reports).
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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash45
- Complete Blockage32
- Fluid/Blood Leak21
- Infusion or Flow Problem13
- Device Contamination with Chemical or Other Material12
- Material Separation11
- Obstruction of Flow8
- Defective Component7
Patient problems
- No Clinical Signs, Symptoms or Conditions133
- No Consequences Or Impact To Patient21
- Insufficient Information9
- No Information4
- No Patient Involvement3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Known Impact Or Consequence To Patient1
- Underdose1
Recent adverse event reports
The 25 most recent of 170 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830717 ↗MalfunctionSep 18, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830715 ↗MalfunctionSep 18, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830714 ↗MalfunctionSep 18, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830710 ↗MalfunctionSep 14, 2026Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763186 ↗MalfunctionSep 3, 2026Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50594852 ↗MalfunctionAug 25, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50439054 ↗MalfunctionJun 22, 2026Leak/Splash; Material Separation
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EARLIER TODAY, THIS PARTICULAR FILTER CAME APART DURING THE COMPOUNDING PROCESS. IT SEEMED TO BE A CLEAN BREAK AT THE JUNCTION BETWEEN THE TUBING AND THE FILTER. THESE FILTERS ARE HEAVILY USED ACROSS ALL CENTERS, AND SAFETY IS OF UTMOST CONCERN. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO HARM OR INJURY, BUT WE HAD TO REMAKE THE ENTIRE CHEMOTHERAPY COMPOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25585925 ↗MalfunctionJun 17, 2026Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAS BEEN EXPERIENCING LEAKING FROM THE 0.2 FILTER AROUND 3 TIMES IN THE PAST COUPLE WEEKS. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NONE. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 21-05-2026, MOST RECENT DATE. WHETHER 3 INCIDENTS HAPPENED ON 3 DIFFERENT DATES? YES, THIS HAPPENED ON THREE DIFFERENT DATES. WHETHER 3 INCIDENTS HAPPEN IN 3 DIFFERENT PATIENTS? YES, WITH THREE DIFFERENT PATIENTS. CAN YOU PLEASE PROVIDE THE MATERIAL NUMBER ASSOCIATED WITH REPORTED ISSUE? SKU 20350E. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? LOT#: (10)25105651.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25537325 ↗MalfunctionJun 17, 2026Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAS BEEN EXPERIENCING LEAKING FROM THE 0.2 FILTER AROUND 3 TIMES IN THE PAST COUPLE WEEKS. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NONE CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? (B)(6) 2026, MOST RECENT DATE. WHETHER 3 INCIDENTS HAPPENED ON 3 DIFFERENT DATES? YES, THIS HAPPENED ON THREE DIFFERENT DATES. WHETHER 3 INCIDENTS HAPPEN IN 3 DIFFERENT PATIENTS? YES, WITH THREE DIFFERENT PATIENTS. CAN YOU PLEASE PROVIDE THE MATERIAL NUMBER ASSOCIATED WITH REPORTED ISSUE? SKU 20350E. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? LOT # (10)25105651.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25537322 ↗MalfunctionJun 17, 2026Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAS BEEN EXPERIENCING LEAKING FROM THE 0.2 FILTER AROUND 3 TIMES IN THE PAST COUPLE WEEKS. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NONE. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? (B)(6) 2026, MOST RECENT DATE. WHETHER 3 INCIDENTS HAPPENED ON 3 DIFFERENT DATES? YES, THIS HAPPENED ON THREE DIFFERENT DATES. WHETHER 3 INCIDENTS HAPPEN IN 3 DIFFERENT PATIENTS? YES, WITH THREE DIFFERENT PATIENTS. CAN YOU PLEASE PROVIDE THE MATERIAL NUMBER ASSOCIATED WITH REPORTED ISSUE? SKU 20350E. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? LOT # (10)25105651.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25537313 ↗MalfunctionMay 31, 2026Complete Blockage
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 0.2 BD FILTER CLOGGED WHILE INFUSING. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WHAT WAS THE PATIENT OUTCOME? NO PATIENT ISSUE. WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? MED WAS BEING GIVEN AT THE TIME WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? JUST INCREASE IN LENGTH OF TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25344445 ↗MalfunctionMay 29, 2026Obstruction of Flow
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER THAT THE FILTER CLOGGED AGAIN AFTER CHANGING OUT THE FIRST CLOGGED FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25326815 ↗MalfunctionMay 29, 2026Obstruction of Flow
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER THAT THE FILTER CLOGGED AGAIN AFTER CHANGING OUT THE FIRST CLOGGED FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25326539 ↗MalfunctionMay 28, 2026Obstruction of Flow
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER THAT THE FILTER CLOGGED WHILE INFUSING CYRAMZA INTO A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25322539 ↗MalfunctionMay 19, 2026Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT 0.2 FILTER CLOGGED/MADE THE PUMP REGISTER THAT IT'S OCCLUDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25219137 ↗MalfunctionMay 15, 2026Mechanical Problem
THE AST TEMECULA, CA FACILITY RECEIVED A MEDWATCH REPORT#: MW5185572, INDICATING THE BD SMARTSITE LOW SORBING EXTENSION SET 0.2 MICRON FILTER WAS CLOGGING/MALFUNCTIONING DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25191148 ↗MalfunctionMay 14, 2026Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSIT EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT WHEN DISCONNECTING THE FILTER FROM THE LINE - THE FILTER DID HAVE PRESSURE CONFIRMING THAT IT WAS CLOGGED AND MEDICATION STARTED LEAKING OUT OF THE FILTER LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25178193 ↗MalfunctionMay 14, 2026Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE FILTER WAS CLOGGED AND BUBBLES IN LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25178192 ↗MalfunctionMay 14, 2026Leak/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 WHEN DISCONNECTING THE FILTER FROM THE LINE - THE FILTER DID HAVE PRESSURE CONFIRMING THAT IT WAS CLOGGED AND MEDICATION STARTED LEAKING OUT OF THE FILTER LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25177765 ↗MalfunctionMay 14, 2026Air/Gas in Device
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET HAD AIR IN LINE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE FILTER WAS CLOGGED AND BUBBLES IN LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25176791 ↗MalfunctionApr 22, 2026Complete Blockage
IT IS REPORTED, CLOGGED/DEFECTIVE FILTER. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955747 ↗MalfunctionApr 21, 2026Fluid/Blood Leak; Leak/Splash
ADDITIONAL INFORMATION: THE LEAKING IS COMING FROM THE FILTER HOUSING (AIR ELIMINATING SIDE). HAVE ALSO BEEN TOLD UPON PRIMING THE FILTER IS LEAKING WITH PRIME SOLUTION AT THE VENT OF THE FILTER. IT OCCURRED WITH DURVALUMAB WHICH RAN AT 140ML/HR AND IT LEAKED AROUND TEN MINUTES INTO THE INFUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24946844 ↗MalfunctionApr 16, 2026Complete Blockage
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24903473 ↗MalfunctionApr 13, 2026Complete Blockage
IT WAS REPORTED, FILTER CLOG ON A MEDICATION TODAY. ADDITIONAL INFORMATION: NO PATIENT HARM/INJURY HAPPENED. PATIENT'S TREATMENT INFUSION TIME WAS EXTENDED DUE TO FILTER HAVING TO BE CHANGED OUT MID TREATMENT. NURSING'S TIME ON PATIENT WAS EXTENDED WHICH BACKED THE RN UP ON HER OTHER PATIENTS. CHAIR TIME WAS EXTENDED IN THE UNIT DUE TO THE EXTENDED INFUSION TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24860975 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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