Alaris, SmartSite 10016072Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403234071), received between Sep 20, 2018 and Jul 24, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT EXT SET 3W-STCK STD HI FLOW 1SS TUBING KINKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 10016072 BATCH NO.: UNKNOWN. IT WAS REPORTED THAT THE LINE LOOPS AROUND AND KINKS AT THE LOOP. THE OTHER ISSUE WITH THIS SET IS STILL A PROBLEM. THE LINE GOES IN THE ARM (ON AN ARMBOARD) AND THEN LOOPS AROUND AND COME BACK TO THE HEAD AND THE ANESTHESIOLOGIST. THE LINE HAS KINKED AT THE LOOP WHICH IS AN ISSUE. THE ARM CAN BE UNDER A DRAPE SO WHEN IT HAS KINKED, THE ANESTHESIOLOGIST MAY NOT SEE. THAT LINE BECOMES USELESS ONCE KINKED. THIS HAPPENS REGULARLY.

  Patient problems: No Patient Involvement

  MAUDE report 10320198 ↗
• MalfunctionJul 24, 2020Backflow; Leak/Splash; Backflow; Leak/Splash

  IT WAS REPORTED THAT EXT SET 3W-STCK STD HI FLOW 1SS CAME APART AND THE PATIENT BLED FROM IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 10016072 BATCH NO.: UNKNOWN. IT WAS REPORTED THE ITEM CAME APART IN THE OR WHICH RESULTED IN BLEEDING OF A PEDS PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10320154 ↗
• MalfunctionNov 4, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE RN FOUND BLOOD ON THE PATIENT'S BED LINENS. UPON ASSESSMENT, IT WAS FOUND THAT THE TUBING SET HAD SEPARATED FROM THE DISTAL PORT CLOSEST TO THE PATIENT DURING USE IN THE ADULT OPERATING ROOM. AT THE TIME, THE PATIENT WAS UNDERGOING A SURGICAL PROCEDURE WITH LACTATED RINGERS INFUSING AT AN UNKNOWN RATE, AS WELL AS OTHER MEDICATIONS, BEING GIVEN THROUGHOUT THE PROCEDURE. THE TUBING SET WAS OPENED AND REMOVED FROM THE PACKAGE AND PLACED INTO USE THAT DAY. THE CUSTOMER LATER CONFIRMED, THAT THERE WAS NO HARM OR ADVERSE EFFECTS CAUSED TO THE ADULT PATIENT FROM THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9274794 ↗
• MalfunctionNov 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE TUBING SET HAD SEPARATED FROM THE DISTAL PORT CLOSEST TO THE PATIENT DURING USE IN THE ADULT OPERATING ROOM. AT THE TIME, THE PATIENT WAS UNDERGOING A SURGICAL PROCEDURE WITH LACTATED RINGERS INFUSING AT AN UNKNOWN RATE, AS WELL AS, OTHER MEDICATIONS BEING GIVEN THROUGHOUT THE PROCEDURE. THE TUBING SET WAS OPENED AND REMOVED FROM THE PACKAGE AND PLACED INTO USE THAT DAY. THE CUSTOMER LATER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE ADULT PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9274534 ↗
• MalfunctionSep 20, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE TUBING LEAKED AT THE CONNECTION. NO PATIENT HARM WAS REPORTED. AFTER THE EVENT, THE EVENT REPORTER BELIEVES THAT THERE MAY HAVE BEEN A DROP OF FLUID ON THE GLAND AFTER THE SYRINGE WAS DISCONNECTED WHICH IS EXPECTED PRODUCT BEHAVIOR, HOWEVER THE PRODUCT WAS NOT SAVED AFTER THE EVENT. NURSING LEADERSHIP ARRANGED FOLLOW UP TRAINING FOR STAFF ON PRODUCT USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7896478 ↗