Alaris, SmartSite 10813621Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885403234514), received between Jan 13, 2020 and Jun 3, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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. Jul 8, 2025Class IOpen, Classified

   Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

   Z-2180-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD A KINK / BEND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE HAVING ISSUES AGAIN WITH SET 10813621, LOT # 26015041 & 25095372. TUBING ALL SEEMS TO BE KINKED/BENT AT THE 3-PORT MANIFOLD WHERE THE TUBING GOES INTO THE MANIFOLD. IT APPEARS THAT THE TUBING IS BENDING BECAUSE THE PACKAGE ISN¿T LONG ENOUGH TO ACCOMMODATE THE LENGTH OF THE TUBING. WERE THERE ANY ADVERSE EVENTS OR PATIENT HARM ASSOCIATED WITH THIS OCCURRENCE? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25378242 ↗
• MalfunctionJun 3, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD A KINK / BEND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE HAVING ISSUES AGAIN WITH SET 10813621, LOT # 26015041 & 25095372. TUBING ALL SEEMS TO BE KINKED/BENT AT THE 3-PORT MANIFOLD WHERE THE TUBING GOES INTO THE MANIFOLD. IT APPEARS THAT THE TUBING IS BENDING BECAUSE THE PACKAGE ISN¿T LONG ENOUGH TO ACCOMMODATE THE LENGTH OF THE TUBING. WERE THERE ANY ADVERSE EVENTS OR PATIENT HARM ASSOCIATED WITH THIS OCCURRENCE? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25378237 ↗
• MalfunctionMay 11, 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 04/19 WHILE DOING MY SAFETY CHECKS BEFORE STARTING CARES, THEY NOTICED FLUID ON THE FLOOR UNDERNEATH THE BED, AND IT WAS VERY STICKYLIKE TPN. THEY SAW IT DRIPPING FROM THE END OF THE BED. AFTER TRACING MY LINES, THEY FOUND DROPS ON THE IV TUBING AND AROUND THE JUNCTION WHERE THE MED PORT ON THE IV PUMP INFUSION SET IS LOCATED. THEY SHOWED ACTION RN A. XXXXX AND NOTIFIED THE NNP A. XXXXX. GRABBED A BLOOD GLUCOSE WHICH WAS 90 AND THE NNP ORDERED NEW FLUIDS TO HANG. THEY PLACED A STICKER WHERE THEY NOTICED THE LEAKING OCCURRING ON TO THE TUBING EXTENSION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144070 ↗
• MalfunctionMar 16, 2026Infusion or Flow Problem

  IT WAS REPORTED BY CUSTOMER THEY EXPERIENCED FLOW ISSUES WITH ALARIS SMARTSITE AND RE-STUCK A PATIENT UNDER THE ASSUMPTION THE IV WAS FAILING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607727 ↗
• MalfunctionFeb 24, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT 10813621 SET DOESN'T HAVE THE ANTIREFLUX VALVES AND FLUIDS ARE LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21455118 ↗
• MalfunctionJan 30, 2024Leak/Splash; Material Separation; Leak/Splash; Material Separation

  NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL#: 10813621, LOT#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT THE ONE OF THEM LEAKED FROM THE CLEAR PLASTIC PART AND THE CLEAN SPLIT IN HALF. VERBATIM: 2 EVENT WITH TUBING 10813621 IN THE PAST MONTH. ONE OF THEM LEAKED FROM THE CLEAR PLASTIC PART AND THE CLEAN SPLIT IN HALF. SEE PICTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610061 ↗
• MalfunctionJan 30, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: VERBATIM: 2 EVENT WITH TUBING 10813621 IN THE PAST MONTH. ONE OF THEM LEAKED FROM THE CLEAR PLASTIC PART AND THE CLEAN SPLIT IN HALF. SEE PICTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18609833 ↗
• MalfunctionFeb 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THERE WAS A TUBING SEPARATION. THE EVENT OCCURRED IN THE OPERATING ROOM AS IT WAS BEING "REMOVED". IT WAS NOTED THAT PLASMA-LYTE WAS INFUSING KVO AT THE TIME OF THE EVENT. PER THE REPORTER; "TRIED TO REMOVE A PIECE OF TAPE THAT WAS WRAPPED AROUND THE TUBING AND THE TUBING WAS SEVERED BY THE TAPE". IT WAS CONFIRMED THAT THE TAPE WAS NOT PRESENT UPON OPENING OF PACKAGING, AND WAS USED TO "SECURE". THERE WAS NO HARM TO THE USER, AS "THE TUBING WAS CLAMPED PROXIMALLY AND DISTALLY AFTER IT SEPARATED". IT WAS FURTHER CONFIRMED DURING FOLLOW UP THAT PATIENT CARE WAS NOT DELAYED AND THAT THIS EVENT DID NOT CONTRIBUTE TO, OR RESULT IN A SERIOUS ADVERSE IMPACT TO PATIENT. HOWEVER; IT WAS ALSO NOTED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 9717601 ↗
• MalfunctionJan 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE ALARIS INFUSION TUBING SPONTANEOUSLY SEPARATED.

  Patient problems: No Information

  MAUDE report 9630508 ↗
• MalfunctionJan 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE ALARIS INFUSION TUBING SPONTANEOUSLY SEPARATED WHILE MEDICATION WAS BEING INFUSED. THE SEPARATION WAS PICKED UP WHEN THE PUMP KEPT ALARMING AIR IN LINE. NO ENTRAINED AIR REACHED THE PATIENT. THERE HAS BEEN NO FURTHER IMPACT TO PATIENT RESPONSE OR ADDITIONAL EVENT INFORMATION MADE AVAILABLE TO DATE.

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

  MAUDE report 9630496 ↗
• MalfunctionJan 13, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE STOPCOCKS ¿ARE BACKWARDS¿. IT WAS OBSERVED THAT "THESE ARE NO TAB FOR OFF AND SHORT TABS FOR ON." THE CLINICIAN STATES THAT "UNLESS YOU TURN OFF THE STOPCOCK AFTER SETTING IT UP, YOU¿LL GET SPLASHED WITH BLOOD/FLUID/ETC., WHEN YOU TAKE OFF THE WHITE PORT CAP." IT WAS REPORTED THAT THERE WAS NO USER OR PATIENT HARM. THE EVENT DID NOT RESULT IN A DELAY THAT SIGNIFICANTLY IMPACTED PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9580867 ↗