Alaris, SmartSite 10879047Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885403232275), received between Jul 11, 2018 and Apr 1, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Backflow” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2020Crack; Crack

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "THE NURSE STATED THAT WHEN SHE PUT IN TUBING INTO THE ALARIS PUMP, IT KEPT ALARMING AND MAKING LARGE VOLUMES OF AIR IN THE TUBING. WHEN SHE REMOVED THE TUBING FROM THE PUMP TO INSPECT IT, SHE NOTICED A CRACK IN THE TUBING ABOVE THE BLUE PLASTIC PIECE." THERE WAS NO PATIENT HARM. AN INCOMPLETE DATE OF EVENT OF (B)(6) 2020 WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913530 ↗
• MalfunctionOct 2, 2019Backflow; Backflow

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "SECONDARY TUBING STARTED TO FREE FLOW WHEN UNCLAMPED IT WAS STOPPED AND PUMPS AND SECONDARY TUBING WERE CHANGED AGAIN, BEGAN TO FREE FLOW- NOTED IT TO BE FLOWING INTO PRIMARY BAG PRIMARY TUBING WAS CHANGED AND IT NO LONGER FREE FLOWED INTO PRIMARY BAG AFTERWARD ANTIREFLUX VALVE APPEARED TO BE DEFECTIVE" AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 9145990 ↗
• MalfunctionOct 2, 2019Backflow; Backflow

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MAUDE REPORT FROM THE FDA WHICH STATES, "BACK CHECK VALVE FAILED ON THE PRIMARY BD ALANS PUMP INFUSION SET PRIMARY WAS SET UP AND RUNNING WHEN RN HOOKED UP THE SECONDARY TO RUN IV ANTIBIOTIC (PRIMARY WAS ON EXTENDER AND SECONDARY WAS HUNG HIGH) THE ENTIRE BAG FLOWED INTO THE PRIMARY BACK. RN CONTACTED THE PROVIDER AND GAVE THE ENTIRE 500 ML BAG WITH ANTIBIOTIC TO THE PATIENT." AN INCOMPLETE DATE OF EVENT OF(B)(6) 2019 WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 9145533 ↗
• MalfunctionJan 15, 2019Complete Blockage; Material Twisted/Bent; Complete Blockage; Material Twisted/Bent

  THE CUSTOMER REPORTED ISSUES WITH TUBING WHERE SETS KINKED AND WERE UNABLE TO PRIME. FOR ONE INSTANCE, A PATIENT¿S BLOOD PRESSURE HAD DROPPED TO 52 AND THE CLINICIAN WAS ATTEMPTING TO PRIME THE TUBING TO START A NEW MEDICATION. THE DIFFICULTY PRIMING RESULTED IN A DELAY UNTIL NEW TUBING WAS OBTAINED. THE SET WAS NOT ATTACHED TO THE PATIENT AT THE TIME OF THE EVENT. NO PATIENT HARM WAS REPORTED AND THE SET WAS SEQUESTERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8248571 ↗
• MalfunctionNov 12, 2018Material Deformation; Material Deformation

  THE CUSTOMER REPORTED THAT THE IV TUBING SET DEVELOPED A BALLOON IN THE PUMPING SEGMENT WHILE INSERTED IN THE PUMP MODULE AND INFUSING IV FLUIDS WHICH CAUSED THE PUMP TO ALARM THAT THERE WAS AN ERROR. THERE WAS NO IV PUSH PERFORMED PRIOR TO THE EVENT OF THE BALLOON OCCURRING IN THE SILICONE PUMPING SEGMENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8060893 ↗
• MalfunctionJul 11, 2018Break; Break

  THE CUSTOMER REPORTED THAT THE TUBING BROKE AND THAT A PATIENT CARE ALERT/INCIDENT/SAFETY REPORT WAS INTERNALLY GENERATED TO DOCUMENT THIS EVENT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7678076 ↗