Alaris, SmartSite 10013902Recalls & reported problems

Summary

The FDA's MAUDE database contains 234 adverse event reports that list this exact device (DI 10885403233814), received between Oct 9, 2018 and Mar 23, 2026 — classified as 4 injuries, 230 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (96 reports).

1 FDA recall record name this device's identifier, 1 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. Oct 11, 2023Class IIOpen, Classified

   Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

   Z-0351-2024 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 234 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Crack; Leak/Splash

  IT WAS REPORTED BY CUSTOMER THAT THERE WAS A CRACK VERTICALLY IN THE FILTER TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662052 ↗
• MalfunctionMar 19, 2026Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT 0.2 MICRON LOW PROTEIN BINDING FILTER MEDICATION LEAKS FROM FILTER UPON INJECTION, LEAKING FROM BACKSIDE OF FILTER. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640146 ↗
• MalfunctionMar 17, 2026Separation Failure; Separation Problem

  IT WAS REPORTED BY A CUSTOMER THAT THE TUBBING BREAKS WHEN THEY TRY TO CONNECT TO THE FILTER. ADDITIONAL INFORMATION: THERE WAS NO PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. A NEW IV BAG WAS MADE FOR THE PATIENT. IT MAINLY CAUSED A SHORT DELAY IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618422 ↗
• MalfunctionMar 17, 2026Separation Failure; Separation Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618421 ↗
• MalfunctionJan 12, 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 THE CUSTOMER THAT LEAKING OUT OF HOLE IN FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24047002 ↗
• MalfunctionJan 2, 2026Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT MEDICATION LEAKED DURING ADMINISTRATION FROM THE AREAS WHERE THE FILTER CONNECTS TO THE EXTENSION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23945544 ↗
• MalfunctionJan 2, 2026Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER THAT THE CHEMOTHERAPY FILTER WAS DRIPPING ONTO THE FLOOR AND PATIENT RECEIVED ONLY GOT 50% OF THE ETOPOSIDE MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23945526 ↗
• MalfunctionDec 31, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON PREPARATION FOR COMPOUNDING, A TECHNICIAN OBSERVED A LEAKY MICRON FILTER INCLUDED W/ A BD SMARTSITE LOW SORBING EXTENSION SET (REF: 10013902). THIS WAS OBSERVED PRIOR TO COMPOUNDING OF DRUG AND IV FLUID + TUBING W/ FILTER HAVE BEEN SEQUESTERED IN WW MAIN PHARMACY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23938598 ↗
• MalfunctionDec 8, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT EXPERIENCED LEAKING OF MEDICATION FROM THE CONNECTION BETWEEN THE TUBING AND THE LINE; THE AREAS WHERE LEAKING OCCURRED IS CIRCLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752267 ↗
• MalfunctionDec 8, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT EXPERIENCED LEAKING OF MEDICATION FROM THE CONNECTION BETWEEN THE TUBING AND THE LINE; THE AREAS WHERE LEAKING OCCURRED IS CIRCLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751825 ↗
• MalfunctionDec 8, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT EXPERIENCED LEAKING OF MEDICATION FROM THE CONNECTION BETWEEN THE TUBING AND THE LINE; THE AREAS WHERE LEAKING OCCURRED IS CIRCLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751824 ↗
• MalfunctionDec 8, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT EXPERIENCED LEAKING OF MEDICATION FROM THE CONNECTION BETWEEN THE TUBING AND THE LINE; THE AREAS WHERE LEAKING OCCURRED IS CIRCLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751823 ↗
• MalfunctionNov 16, 2025Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23565847 ↗
• MalfunctionNov 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE FILTER BREAKING AND LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497917 ↗
• MalfunctionNov 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE FILTER BREAKING AND LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497902 ↗
• MalfunctionNov 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS CRACKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING IT WAS REPORTED BY CUSTOMER THAT THE FILTER BREAKING AND LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497884 ↗
• MalfunctionOct 29, 2025Complete Blockage; Complete 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. THE FILTER ON THE TUBING WASN'T WORKING AND FLUID WAS NOT ABLE TO PASS THROUGH IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416959 ↗
• MalfunctionOct 29, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET HAD CONNECTION ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM WHILE CONNECTING XXXXX (ON SECONDARY LINE) TO NS (ON PRIMARY LINE) THE FILTER CAME OFF. THIS NURSE INSERTED PRIMARY TUBING INTO THE CHANNEL AND CONNECTED TO PT'S PIV. DOUBLE CHECKED NAME ON LABELED LIBTAYO TO WRIST BAND WITH PT STATING NAME/DOB (CONFIRMED), HUNG XXX ON IV POLE HOOK, PLACED TUBING IN THE CHANNEL, AND CLOSED THE DOOR. WIPED THE PORT CLOSET TO THE CLAMP WITH ALCOHOL TO CONNECT THE XXXX TO THE PRIMARY TUBING. WHEN REACHING FOR THE END CAP OF THE XXXX LINE, THE LINE DISCONNECTED/BROKE AWAY FROM THE FILTER (SEE PICTURES) AND WAS UNABLE TO RECONNECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416951 ↗
• MalfunctionOct 29, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: COMPOUNDING TECHNICIAN SPOTTED THAT THE FILTER WAS LEAKING NS BEFORE CHEMOTHERAPY MEDICATION WAS ADDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416899 ↗
• MalfunctionOct 29, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: PT'S HUSBAND CALLED OUT SAYING THE CHEMO WAS LEAKING. RN STOPPED INFUSION. LEAK COMING FROM FILTER ON CHEMO TUBING. CHEMO BAG AND TUBING GIVEN TO PHARMACIST AND CHEMO SPILL CLEANED UP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416898 ↗
• MalfunctionOct 29, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: RN WENT TO TURN OFF PATIENT'S IV FLUSH. SHE NOTICED FLUID ON THE FLOOR. FLUID WAS LEAKING AROUND THE FILTERED TUBING RIGHT AFTER THE IV PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416896 ↗
• MalfunctionOct 29, 2025Break; Leak/Splash; Separation Problem; Break; Leak/Splash; Separation Problem

  ADDITIONAL INFORMATION: I HAD SPIKED THE IV BAG AND STARTED TO PRIME IT WHEN THE TUBING CAME APART AND ABOUT 10 ML SPILLED ON FLOOR BEFORE I CLAMPED TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415761 ↗
• MalfunctionOct 20, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT HAS AN IV REMODULIN INFUSION RUNNING THROUGH HER PORT WHICH REQUIRES A VERY SPECIFIC DOSAGE, INCLUDING KEEPING IT RUNNING CONTINUOUSLY WITH NO STOPPING. THIS MEDICATION ALSO REQUIRES A 0.2 MICRON FILTER AT THE END OF THE INFUSION LINE. UPON GETTING THE PATIENT UP TO FOR THE BATHROOM, WE NOTICED THAT THE 0.2 MICRON FILTER WAS DISCONNECTED FROM THE PATIENT, IT HAD BROKEN WITHIN THE FILTER LINE, WHICH CAUSED AN UNKNOWN AMOUNT OF TIME THE PATIENT WAS DISCONNECTED FROM REMODULIN. UPON INSPECTION THE FILTER HAD SNAPPED OFF. WE SUBSEQUENTLY REPRIMED A NEW FILTER WITH THE REMODULIN AND RECONNECTED/RESTARTED THE MEDICATION. WAS THERE INJURY? NO, REACHED THE INDIVIDUAL BUT DID NOT CAUSE HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336380 ↗
• MalfunctionSep 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE LOW SORBING SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER THE PATIENT WAS ROLLED ONTO BEDPAN, IT WAS DISCOVERED THAT THE PIGTAIL ON THE FILTER ATTACHED TO THE REMODULIN DRIP HAD DISLODGED AND NOW IN 2 PIECES. THE MEDICATION WAS NO LONGER CONNECTED TO HER, AND HER PICC LINE HAD BACKED UP WITH BLOOD. ANOTHER FILTER WAS WITHIN REACH, AND THE LINE WAS QUICKLY RE-ASSEMBLED WITH A NEWLY PRIMED FILTER. AFTER PULLING WASTE, REPLACING THE CLAVE, AND PREPARING HER PICC, THE PATIENT WAS OFF THE MEDICATION APPROXIMATELY 10-15 MINUTES. SHE DID NOT HAVE ANY COMPLICATIONS AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22945713 ↗
• MalfunctionSep 2, 2025Gas/Air Leak; Gas/Air Leak

  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 AIR BUBBLES BEING TRAPPED IN THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935494 ↗