Alaris, SmartSite 11590100Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885403232411), received between Jun 19, 2019 and Mar 4, 2020 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NURSE FOUND A PUDDLE OF FLUID ON THE FLOOR. THE TUBING WAS THEN INSPECTED AND FOUND A HOLE WHERE THE LEAK WAS COMING FROM. TOTAL PARENTERAL NUTRITION (TPN) WAS INFUSING THROUGH A CENTRAL LINE AT THE TIME OF THE EVENT. THERE WAS A DELAY IN INFUSION THERAPY DUE TO CHANGING OF INTRAVENOUS FLUID. THE PATIENT WAS THEN CHECKED FOR INFECTION AND THERE WAS NO PATIENT HARM. THE EVENT OCCURRED IN THE NEONATAL INTENSIVE CARE UNIT (NICU).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9787435 ↗
• MalfunctionMar 4, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SPIKE'S TIP BROKE OFF UPON SPIKING THE TOTAL PARENTERAL NUTRITION (TPN) BAG. THE NURSE DISCOVERED THE ISSUE AS THE PART THAT BROKE OFF WAS SEEN BLOATING IN THE MEDICATION BAG. THERE WAS A DELAY IN INFUSION THERAPY DUE TO CHANGING OF IV FLUID. THERE WAS NO PATIENT HARM. THE EVENT OCCURRED IN NEONATAL INTENSIVE CARE UNIT (NICU).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9787373 ↗
• InjuryMar 4, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE NURSE FOUND A PUDDLE OF FLUID ON THE FLOOR. THE TUBING WAS THEN INSPECTED AND FOUND A HOLE WHERE THE LEAK WAS COMING FROM. TOTAL PARENTERAL NUTRITION (TPN) WAS INFUSING THROUGH A CENTRAL LINE AT THE TIME OF THE EVENT. THERE WAS A DELAY IN INFUSION THERAPY DUE TO CHANGING OF THE IV FLUID. THE PATIENT WAS THEN CHECKED FOR INFECTION AND THERE WAS NO PATIENT HARM, HOWEVER; THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS. THE EVENT OCCURRED IN THE NEONATAL INTENSIVE CARE UNIT (NICU). ALTHOUGH IT WAS CONFIRMED THAT THERE WAS A DELAY IN PATIENT TREATMENT DURING FOLLOW UP, IT WAS ALSO NOTED THAT THERE WAS NO PATIENT HARM OR IMPACT AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9787285 ↗
• MalfunctionSep 19, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT WHILE AWAITING ON PERIPHERAL IV PLACEMENT ON A PATIENT, THE IV TUBING HAD BEEN PRIMED AND PLACED ON THE IV INFUSION PUMP. THE CLINICIAN FOUND A LEAK, OPENED THE DOOR TO THE INFUSION PUMP AND NOTICED THAT THE PUMP SEGMENT OF THE TUBING HAD SEPARATED FROM THE UPPER FITMENT. ALTHOUGH REQUESTED, THERE WAS NO INFORMATION PROVIDED REGARDING PATENT HARM.

  Patient problems: No Patient Involvement

  MAUDE report 9092211 ↗
• MalfunctionSep 19, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE IV TUBING COMES APART JUST BELOW THE PUMP SEGMENT. IT WAS CONFIRMED DURING FOLLOW UP THAT THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

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

  MAUDE report 9089794 ↗
• MalfunctionSep 19, 2019Material Separation; Material Separation

  IT WAS REPORTED THE IV TUBING COMES APART JUST BELOW THE PUMP SEGMENT.

  Patient problems: No Information

  MAUDE report 9087895 ↗
• MalfunctionSep 13, 2019Break; Break

  IT WAS REPORTED THAT THE IV TUBING WAS BEING USED IN NEONATAL INTENSIVE CARE UNIT (NICU) AND THE BOTTOM PART OF THE TUBING, WHERE TWO CLEAR PLASTICS MEET, BROKE APART. THE NURSE TRIED TO PUT IT BACK TOGETHER BUT UNABLE TO DO SO.

  Patient problems: No Information

  MAUDE report 9038918 ↗
• MalfunctionAug 19, 2019Crack; Crack

  IT WAS REPORTED THAT THE TUBING CRACKED.

  Patient problems: No Information

  MAUDE report 8908040 ↗
• MalfunctionJun 19, 2019Material Deformation; Material Deformation

  THE CUSTOMER REPORTED THAT AFTER A 50ML PIPERACILLIN INFUSION THE NURSE NOTED THAT THERE WAS A LARGE ¿BUBBLE¿ IN THE PUMP SEGMENT OF THE TUBING ABOVE THE TOP OF THE INSIDE DOOR. THERE WAS NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8713307 ↗