Alaris, SmartSite 10012283Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885403233692), received between Oct 21, 2019 and Nov 8, 2019 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BURETTE TUBING LEAKED TPN AT AN UNSPECIFIED LOCATION ON THE FILTER . THE EVENT OCCURRED IN NICU. ALTHOUGH REQUESTED CUSTOMER STATED; " I DON'T HAVE SPECIFICS FOR EACH" HOWEVER LEAK OCCURRED TWO DAYS AFTER THE TUBING WAS PRIMED. ALTHOUGH REQUESTED, NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER FOR THIS EVENT. ¿A NOTE ATTACHED TO PRODUCT THAT STATED: THIS IV SET WITH FILTER, THE TUBING WAS HUNG ON (B)(6) 2019. AT 0200 (B)(6) 2019 FILTER NOTED TO BE LEAKING. LOT NUMBER UNKNOWN. THE PACKAGE WITH PRODUCT WAS THE LOT NUMBER OF NEW SET HUNG. TPN INFUSING AT 5.3ML/HR. LIPIDS INFUSING 1.1ML/HR. AND MEDICATION INFUSING THRU THE BEAR CLAW ATTACHED TO PORT DIRECTLY BELOW BUILT IN FILTER.¿

  Patient problems: No Information

  MAUDE report 9298879 ↗
• MalfunctionNov 8, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TPN (250ML) FILTER LEAKED AROUND THE 2 AREAS ON THE BACK OF THE FILTER. YESTERDAY, A PARENT COMPLAINED OF BEING ABLE TO SMELL THE TPN IN HER BABY¿S BED AND SHE WAS CONCERNED THAT THE FILTER WAS LEAKING.¿ THE NURSE OPENED A STERILE 2X2 PACKAGE AND PLACED THE FILTER INSIDE THE PACKAGE AND FOLDED OVER THE PAPER OF THE PACKAGE. SHE RECHECKED IT AFTER AN HOUR BUT THERE WAS NO LEAK. THE RN TRANSFERRED THE BABY OUT OF THE BED FOR THE MOTHER TO HOLD AND SHORTLY THE TPN TUBING LEAKED FROM THE FILTER. THE CUSTOMER STATED: ¿IF YOU POSITION THE FILTER WITH THE BACK SIDE UP AND LEVEL EVENTUALLY YOU WILL HAVE 2 DISTINCT DROPS OF FLUID AROUND THIS AREA.

  Patient problems: No Information

  MAUDE report 9298483 ↗
• MalfunctionNov 8, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BURETTE TUBING LEAKED FLUIDS AT AN UNSPECIFIED LOCATION. ALTHOUGH REQUESTED, CUSTOMER STATED; " I DON¿T HAVE SPECIFICS FOR EACH", AND THERE WAS NO ADDITIONAL EVENT OR PATIENT DETAILS PROVIDED. A NOTE ATTACHED TO PRODUCT FLUIDS; INITIATED ON "10/07 AND LEAKING 10/09". THE EVENT OCCURRED IN THE (NICU).

  Patient problems: No Information

  MAUDE report 9298400 ↗
• MalfunctionNov 8, 2019Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE BURETTE TUBING LEAKED FLUIDS AT AN UNSPECIFIED LOCATION. THE EVENT OCCURRED IN THE NICU. CUSTOMER STATED; " I DON¿T HAVE SPECIFICS FOR EACH OF THE (4), BUT I DO KNOW THAT TWO OF THEM WERE NOTED TO BE LEAKING TWO DAYS AFTER THE TUBING WAS PRIMED". ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL EVENT OR PATIENT DETAILS PROVIDED BY THE CUSTOMER.

  Patient problems: No Information

  MAUDE report 9298399 ↗
• MalfunctionNov 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BURETTE TUBING WITH FILTER LEAKED TPN AT AN UNSPECIFIED LOCATION. THE EVENT OCCURRED IN NICU THERE WAS NO PATIENT HARM REPORTED .ALTHOUGH REQUESTED THERE WAS NO OTHER EVENT DETAILS PROVIDED .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9286679 ↗
• MalfunctionNov 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT (TPN) (250ML) LEAKS AROUND THE FILTER. THE CUSTOMER STATED THAT THE (NICU) NEONATES HAVE EITHER PICC OR IV LINES THAT ARE MATE TO TPN TUBING TO A TRIFUSE FOR 20% INTRALIPIDS AND ANTIBIOTICS INFUSIONS. THE TPN RATES VARIED FROM 5-12 ML/HR. THE RN STATED THE TUBING WAS PRIMED AND HUNG/PRIMED ON SEPTEMBER 30TH AND WAS NOTED TO BE LEAKING FROM THE TPN FILTER ON 10/2. THERE WAS NO OBVIOUS SIGNS OF HARM TO THE PATIENT, HOWEVER; THERE IS A POTENTIAL RISK OF INFECTION. ALTHOUGH REQUESTED, NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9281391 ↗
• MalfunctionNov 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TPN(250ML) LEAKS AROUND THE FILTER. THE CUSTOMER STATED THAT; "THE NICU NEONATES HAVE EITHER PICC OR IV LINES THAT ARE MATE TO TPN TUBING TO A TRIFUSE FOR 20% INTRALIPIDS AND ANTIBIOTICS INFUSIONS. THE TPN RATES VARIED FROM 5-12 ML/HR". THE RN STATED: "TUBING WAS PRIMED AND HUNG/PRIMED ON SEPTEMBER 30TH AND WAS NOTED TO BE LEAKING FROM THE TPN FILTER ON 10/2. THERE WAS NO OBVIOUS SIGNS OF HARM TO THE PATIENT HOWEVER A POTENTIAL RISK OF INFECTION". ALTHOUGH REQUESTED, NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9279877 ↗
• MalfunctionOct 21, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SETS LEAKED FROM THE FILTER DURING PATIENT USE. IT WAS FURTHER CONFIRMED DURING FOLLOW-UP, THAT THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9215893 ↗