Alaris 10012866Recalls & reported problems
BD Switzerland Sàrl · Extension Set, 1.2 Micron Low Protein Binding Filter 43 cm (17 in) · Class 2
Quick summary
This BD Alaris SmartSite extension set is a tubing set with a low protein binding filter, used to deliver IV nutrition and other infusions. The 53 reports mostly describe blocked tubing, blood or fluid backing up into the line, and cracked or leaking tubing and filters, sometimes noticed while priming or in use. No deaths or injuries are reported, and most reports mention no effect on the patient. There are no recalls naming this device, and reports have fallen from 11 in the prior 12 months to 5.
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
- 54
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10885403233777), received between Nov 12, 2018 and Sep 17, 2026 — classified as 54 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (20 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Complete Blockage20
- Backflow7
- Leak/Splash7
- Fluid/Blood Leak6
- Crack4
- Break2
- Connection Problem2
- Defective Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- No Consequences Or Impact To Patient6
- Insufficient Information3
- No Information1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808556 ↗MalfunctionMay 6, 2026Break
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING OR AFTER PRIMING A PATIENT'S MEDICATION, NURSES OBSERVED LEAKAGE CAUSED BY A BROKEN TUBE. IN MOST CASES, THE TUBING EITHER SNAPPED WHILE INSERTED IN THE ALARIS PUMP OR THE ENDS OF THE TUBING WERE FOUND TO BE CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25101586 ↗MalfunctionMar 30, 2026Backflow
IT WAS REPORTED, LIPIDS BACKFLOWING INTO TPN LINE INTO THE FILTER. ADDITIONAL INFORMATION: I BELIEVE THIS CAUSED AN ERROR WITH THE AMOUNT OF LIPIDS AND TPN THE PATIENT RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24729696 ↗MalfunctionFeb 10, 2026Complete Blockage
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24305422 ↗MalfunctionFeb 6, 2026Backflow; Fluid/Blood Leak
IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THERE WAS BLOOD BACKED UP INTO TPN LINE, ALL THE WAY TO THE TPN FILTER. I ALSO NOTICED THE FILTER ITSELF WAS STICKY TO THE TOUCH AROUND THE 2 WHITE CIRCLES ON THE FLAT SIDE OF THE FILTER, WHICH TPN IS VERY STICKY WHEN SPILLED SO THIS ALMOST CERTAINLY IS TPN LEAKING. THERE WERE NO WET SPOTS IN THE PATIENT¿S BED, OR ON THE FLOOR OF FLUID LEAKING. I CALLED THE CN TO LOOK AT THE LINE, AND SHE AGREED THAT I SHOULD CHANGE THE FILTER, FLUSH THE TRIFUSE, AND RESTART THE TPN. I DID SO, AND THE LINE FLUSHED PERFECTLY SO I ATTACHED A NEW FILTER TO THE TPN LINE AND RESTARTED THE INFUSION. I HAD GIVEN ANOTHER IV MEDICATION AT ~0300, AND THE LINE HAD LOOKED LIKE NORMAL. SO, THE FILTER FAILED IN BETWEEN 0300 AND 0400. THIS MAKES ME THINK THE FILTER WAS FAULTY BECAUSE IT WAS LEAKING TPN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24281743 ↗MalfunctionJan 28, 2026Leak/Splash
IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT TPN FILTER WAS FOUND LEAKING BY A BEDSIDE NURSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24204409 ↗MalfunctionOct 29, 2025Crack; Crack
IT WAS REPORTED THAT THE BD ALARIS EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE AND LEAKING ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE IS THERE ANY DEFECT/ ISSUE FOUND APART FROM LEAKAGE? THE MICRON LOW PROTEIN BINDING FILTER WAS FOUND TO HAVE STARTED LEAKING THROUGH A SMALL CRACK. TPN AND LIPIDS WERE INFUSING THROUGH THE FILTER. THIS HAS BEEN REPORTED AS HAPPENING TO MULTIPLE FILTERS THROUGHOUT THE PAST FEW WEEKS. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? THE FIRST REPORTED DATE WAS (B)(6) 2025 AND THERE HAVE BEEN A FEW AFTER WITH NO DATE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23417401 ↗MalfunctionOct 29, 2025Crack; Crack
IT WAS REPORTED THAT THE BD ALARIS EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE AND LEAKING, ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE IS THERE ANY DEFECT/ ISSUE FOUND APART FROM LEAKAGE? THE MICRON LOW PROTEIN BINDING FILTER WAS FOUND TO HAVE STARTED LEAKING THROUGH A SMALL CRACK. TPN AND LIPIDS WERE INFUSING THROUGH THE FILTER. THIS HAS BEEN REPORTED AS HAPPENING TO MULTIPLE FILTERS THROUGHOUT THE PAST FEW WEEKS. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MM-YYYY? THE FIRST REPORTED DATE WAS 5/23/2025 AND THERE HAVE BEEN A FEW AFTER WITH NO DATE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23417396 ↗MalfunctionSep 11, 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 THE CUSTOMER THAT ONE OF THE PICC FLUID LINES WAS LEAKING. UPON FURTHER INSPECTION IT WAS THE LARGE BORE FILTER THAT WAS LEAKING FROM THE FILTER ITSELF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23028062 ↗MalfunctionJul 17, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS BROKE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT BD EXTENSION SET 1.2-MICRON LOW PROTEIN BINDING FILTER BROKE OFF INTO TRIFUSE. NURSE WAS HAVING DIFFICULTIES TRYING TO GET EXTENSION OFF TRIFUSE. WHEN NURSE WAS ABLE TO GET IT OFF PART OF THE PLASTIC BROKE OFF INTO THE TRIFUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22536182 ↗MalfunctionJul 8, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET HAD BACKFLOW. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT THE REMICADE WAS PRIMED PROPERLY WITH FILTER ATTACHED AND ORIENTED IN CORRECT POSITION. TUBING WAS CLAMPED IN MULTIPLE LOCATIONS, BUT WHEN IT WAS ATTACHED TO PATIENT, BLOOD RETURN WAS NOTED TO BE BACKING UP INTO TUBING AND AIR WAS ALSO NOTED TO BE PRESENT EVEN THOUGH CLAMPS WERE STILL ENGAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22435168 ↗MalfunctionJun 30, 2025Backflow; Backflow
NO ADDITIONAL INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22353621 ↗MalfunctionMay 14, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS EXTENSION PUMP WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM THE TUBING LEAKED LIPIDS DESPITE BEING CLAMPED USING THE EXTENSION SET¿S CLAMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22023266 ↗MalfunctionMay 14, 2025Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT BD ALAIRIS EXTENSION SET HAD AIR IN LINE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM TUBING INFUSING LIPIDS ENTRAINED AIR LARGER THAN CHAMPAGNE BUBBLES PAST THE FILTER, HAD TO BE CHANGEDÀ CLABSI RISK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22023257 ↗MalfunctionMay 14, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT THE FILTER WILL NOT PRIME LIPIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22023255 ↗MalfunctionApr 30, 2025Defective Component; Defective Component
UPDATED AWARENESS DATE DUE TO ADDITIONAL INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21936966 ↗MalfunctionApr 25, 2025Backflow; Backflow
IT WAS REPORTED THAT THE BD ALARIS EXTENSION SET HAD BLOOD BACKFLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MALFUNCTIONING 1.2 MICRON LOW PROTEIN BINDING FILTER. THIS FILTER WAS ATTACHED AT THE BOTTOM OF A STRAIGHT TUBING INFUSION SET FOR MEDICATION INFUSION. ONCE TUBING IS CONNECTED TO PATIENT PIV WITH INFUSION RUNNING AT 10ML/HR BLOOD IS BACK FILLING INTO THE PIV LINE AND INTO THE TUBING LINE. WHEN THE ENTIRE TUBING LINE IS HELD PERPENDICULAR TO THE GROUND THE BLOOD STOPS BACK FLOWING. WITH ANY PATIENT ARM MOVEMENT UP OR WALKING THE BLOOD BEGINS TO BACKFLOW AGAIN INTO THE TUBING. TURBULENT FLUSH GIVEN TO PIV AND TUBING RECONNECTED. BACK FLOWING BLOOD CONTINUES TO HAPPEN. SIMILAR EVENT WITH OTHER 1.2 FILTERS X3 TIMES IN THE LAST 3 WEEKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21910070 ↗MalfunctionAug 30, 2024Complete Blockage; Complete Blockage
MATERIAL#: UNKNOWN. BATCH NUMBER#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT FLUID WAS NOT FLOWING THROUGH THE LINE PROPERLY THROUGH THE BLUE FILTER. PROCEDURE STOPPED, NEW FILTER USED AND IT WORKED PROPERLY. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. FLUID WAS NOT FLOWING THROUGH THE LINE PROPERLY THROUGH THE BLUE FILTER. PROCEDURE STOPPED, NEW FILTER USED AND IT WORKED PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20111352 ↗MalfunctionAug 6, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS DIFFICULT TO DISCONNECT THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE WHITE CAP WOULD NOT COME OFF, ONE COULDN'T PRIME AND ONE UNKNOWN ISSUE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19916741 ↗MalfunctionJun 27, 2024Defective Component; Failure to Seal; Defective Component; Failure to Seal
IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: PT WAS DISCONNECTED FROM LIPIDS, FOUND IV TUBING HAD BROKEN OFF AT THE END OF THE FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19630639 ↗MalfunctionJun 11, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT HAS BEEN BROUGHT TO MY ATTENTION THAT IN A FEW SEPARATE OCCASIONS THE IV TUBING BELOW WILL BEGIN PRIMING HOWEVER ONCE IT GETS TO THE FILTER IT WILL STOP. INFUSION SET (REFERENCE # (B)(4) ) IS CONNECTED TO A LIPID FILTER (REFERENCE # (B)(4) ). IT WILL PRIME THEN STOPS AT THE FILTER.
Patient problems: Insufficient Information
MAUDE report 19510935 ↗MalfunctionMay 14, 2024Backflow; Backflow
MATERIAL # 10012866 , BATCH # 24019396. IT WAS REPORTED BY CUSTOMER THAT 1.2 MICRON FILTERED TUBING SETS ARE BACKING UP WITH NICU PATIENTS. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. 1.2 MICRON FILTERED TUBING SETS ARE BACKING UP WITH NICU PATIENTS.
Patient problems: Insufficient Information
MAUDE report 19309085 ↗MalfunctionFeb 29, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD EXT SET DEHP FREE 1.2MF TUBING DISCONNECTED OR BROKE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REGISTERED NURSE (RN) TURNED ON THE LIGHTS TO ASSESS THE PATIENT AND NOTICED BACKFLOW OF BLOOD INTO TUBING SET. RN INVESTIGATED AND FOUND THAT THE LIPID TUBING FILTER HAD DISCONNECTED/BROKEN, LEAVING LIPIDS TO SPILL ONTO FLOOR AND BLOOD TO BACKFLOW INTO THE TRIFUSE. RN IMMEDIATELY STOPPED THE LIPIDS, CLAMPED THE OLD TUBING AND PRIMED NEW TUBING. BROKEN TUBING WAS SAVED.
Patient problems: Insufficient Information
MAUDE report 18813251 ↗MalfunctionFeb 14, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS EXTENSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: ALARIS PUMP ALARMED THAT SMOF LIPID LINE WAS OCCLUDED. REPOSITIONED EXTREMITY WITH PICC. ALARIS PUMP CONTINUED TO ALARM. DISCONNECTED AND ATTEMPTED TO PRIME SAME LINE. FLUID WAS UNABLE TO PRIME. REPLACED SET AND CONTINUED THE INFUSION. CUSTOMER REPLY: ¿ DESCRIBE THE PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED BECAUSE OF THE EVENT. : THE FILTER HAD TO BE CHANGED, DELAY OF TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18705226 ↗MalfunctionJan 8, 2024Failure to Prime; Failure to Prime
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18472393 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.