Alaris, SmartSite 10012144Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07613203021159), received between Sep 5, 2018 and Nov 12, 2021 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (12 reports).

2 FDA recall records name this device's identifier, 1 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. Sep 11, 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-0035-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 6, 2019Class ITerminated

   An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.

   Z-1770-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS INFUSION SET EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BACK CHECK VALVE FAILURE ¿ 10012144 PRIMARY SET. CONNECTED WAS AN ICU MEDICAL SECONDARY SET CONTAINING CHEMO. THE SECONDARY BAG CONTENTS BACKED UP INTO THE PRIMARY BAG AND THEY SAID THE DRIP CHAMBER WAS FULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12801664 ↗
• MalfunctionNov 11, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS ADMINISTRATION SET EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BACK CHECK VALVE FAILURE. CONNECTED WAS A NON-VENTED SECONDARY SET. THE SECONDARY BAG CONTENTS (ANTIBIOTIC) BACKED UP INTO THE PRIMARY BAG AND THEY SAID THE DRIP CHAMBER WAS FULL. THIS HAPPENED IN THE BONE MARROW TRANSPLANT UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12801076 ↗
• MalfunctionOct 20, 2020Complete Blockage; Restricted Flow rate; Infusion or Flow Problem; Complete Blockage; Restricted Flow rate; Infusion or Flow Problem

  IT WAS REPORTED THAT THE GEM 20DP V/NV CKV 3SS EXPERIENCED KINKED TUBING AND WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10012144 BATCH NO: (AN INVALID LOT # WAS PROVIDED AS 20016683) WE HAD AN ALARIS TUBING INCIDENT YESTERDAY. THE TUBING WAS KINKED BELOW THE DRIP CHAMBER SO FLUID WOULD NOT FLOW INTO THE TUBING, NO MATTER WHAT THEY TRIED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10703499 ↗
• MalfunctionJun 15, 2020Material Separation; Fluid/Blood Leak; Material Separation; Protective Measures Problem

  IT WAS REPORTED THAT THE NURSE INITIATED A TPN INFUSION IN WHICH THE DEVICE CONTINUOUSLY ALARMED FOR AIR IN LINE. WHILE TROUBLESHOOTING, THE TUBING SET SEPARATED AT THE UPPER FITMENT AND LEAKED TPN ON THE NURSE AND PATIENT.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 10155023 ↗
• MalfunctionJun 11, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PRIMARY TUBING SET SEPARATED AT THE BLUE SAFETY CLAMP. ALTHOUGH REQUESTED, THERE WAS NO REPORTED IMPACT TO THE PATIENT OR USER AVAILABLE TO DATE.

  Patient problems: No Information

  MAUDE report 10145586 ↗
• MalfunctionAug 27, 2019Break; Crack; Fluid/Blood Leak; Break; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EVENT OCCURRED IN THE OPERATING ROOM WHEN THE MD ANESTHESIOLOGIST ATTEMPTED TO PUT A 20 ML SYRINGE ONTO MIDDLE NEEDLELESS PORT. THE SYRINGE WAS PUSHED BACK OFF OF THE NEEDLELESS PORT, HALF OF THE PORT CRACKED/BROKE OFF, AND THE FLUID WAS POURING OUT OF THE SITE. THE LACTATED RINGER'S SOLUTION (LR) WERE INFUSING AT THE TIME OF THE EVENT. THE TUBING WAS QUICKLY CHANGED AND THE MEDICATION WAS CONTINUED FOR THE PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8935847 ↗
• InjuryJul 16, 2019Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A CALCIUM GLUCONATE INFUSION FOR A PATIENT RECEIVING DIALYSIS, THE TUBING LEAKED AT THE NEEDLELESS PORT CLOSEST TO THE PATIENT RESULTING IN BLOOD BACKING UP INTO THE TUBING. FLUID AND BLOOD LEAKED OUT OF THE NEEDLELESS PORT INTO THE FLOOR OVER AN HOUR. THE PATIENT BECAME HYPOCALCEMIC, SYMPTOMATIC, WITH A SMALL AMOUNT OF BLOOD LOSS. NO OTHER PATIENT EFFECTS WERE REPORTED.

  Patient problems: Blood Loss; Therapeutic Effects, Unexpected; Therapeutic Response, Decreased

  MAUDE report 8796203 ↗
• InjuryJul 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE DIALYSIS NURSE NOTED THAT THE TUBING WAS LEAKING OUT OF THE PORT CLOSEST TO THE PATIENT CONNECTION. THE PATIENT'S 100ML CALCIUM GLUCONATE INFUSION WAS DRIPPING OUT INSTEAD OF INFUSION FOR 1 HOUR AND BLOOD FROM THE PATIENT'S CATHETER WAS BACK FLOWING OUT OF THE SAME PORT. THE PATIENT BECAME HYPOKALEMIC, SYMPTOMATIC, AND HAD A SMALL AMOUNT OF BLOOD LOSS. ALTHOUGH REQUESTED, THERE WERE NO FURTHER DETAILS OR INFORMATION PROVIDED AND NO REPORT OF LASTING HARM.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 8782423 ↗
• MalfunctionMar 25, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE TUBING SEPARATED AT THE UPPER Y-SITE. WHEN THIS OCCURRED DURING THE INFUSION, THE REST OF THE PRODUCT KINKED IN THE PUMP WHICH TRAPPED THE MEDICATION INSIDE THE TUBING. ALTHOUGH REQUESTED, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Information

  MAUDE report 8448917 ↗
• MalfunctionNov 6, 2018Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING A METHOTREXATE INFUSION, THE USER NOTED THAT THE SILICONE SEGMENT SPLIT, CAUSING A LEAK. IT WAS REPORTED THAT THE 24 HOUR INFUSION HAD 3/4 REMAINING WHEN THE EVENT OCCURRED. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8043714 ↗
• MalfunctionNov 6, 2018Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PATIENT ARRIVED ON THE UNIT WITH NORMAL SALINE INFUSING BY GRAVITY. THE USER ATTACHED THE TUBING TO THE DEVICE AND CONTINUED THE INFUSION WITHOUT DIFFICULTY, HRS. LATER A PCA MODULE WAS ATTACHED AND THE PATIENT WENT TO X-RAY. UPON ARRIVING BACK TO THE UNIT, THE USER NOTED A LEAK, WITH FURTHER EXAMINATION IT WAS REPORTED THAT THE TUBING BROKE AT THE UPPER FITMENT OF THE SILICONE SEGMENT AND LEAKED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8043712 ↗
• MalfunctionNov 6, 2018Material Deformation; Material Deformation

  THE CUSTOMER REPORTED A BULGE IN THE SILICONE SEGMENT WHEN INFUSING PRECEDEX. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8043603 ↗
• MalfunctionOct 25, 2018Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE TUBING "SPLIT" BROKE AND LEAKED AT THE UPPER FITMENT OF THE SILICONE SEGMENT, THE SET WAS IN USE FOR 30 MIN WHEN THE LEAK OCCURRED. IT WAS REPORTED THAT A SECONDARY CHEMO SET WAS ATTACHED HOWEVER NOT IN USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8005082 ↗
• MalfunctionOct 25, 2018Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE TUBING "SPLIT" BROKE AND LEAKED AT THE LOWER FITMENT OF THE SILICONE SEGMENT, THE SET WAS IN USE FOR 30- 45 MIN. WHEN THE LEAK OCCURRED. IT WAS REPORTED THAT A SECONDARY MAGNESIUM SET WAS ATTACHED HOWEVER NOT IN USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8005032 ↗
• MalfunctionOct 25, 2018Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE TUBING "SPLIT" BROKE AND LEAKED AT THE LOWER FITMENT OF THE SILICONE SEGMENT, THE SET WAS IN USE FOR 30 MIN WHEN THE LEAK OCCURRED. IT WAS REPORTED THAT A SECONDARY CHEMO SET WAS ATTACHED HOWEVER NOT IN USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8004975 ↗
• MalfunctionOct 11, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE CUSTOMER REPORTED THAT THE SET SEPARATED BETWEEN THE LOWER FITMENT AND THE SAFETY CLAMP CAUSING THE IMMUNE GLOBULIN INFUSION TO LEAK. THE RN REPORTED THAT THE TUBING WAS NOT STRETCHED PRIOR USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7958098 ↗
• MalfunctionOct 11, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE CUSTOMER REPORTED THAT THE SET SEPARATED BETWEEN THE LOWER FITMENT AND THE SAFETY CLAMP CAUSING THE LUMIZYME INFUSION TO LEAK.THE RN REPORTED THAT THE TUBING WAS NOT STRETCHED PRIOR USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7957978 ↗
• MalfunctionSep 5, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT A NEW BAG OF NOREPINEPHRINE WAS STARTED AT 0930. ONE HOUR LATER THE BAG WAS EMPTY WITH FLUID ON THE FLOOR DIRECTLY UNDER THE IV POLE. THE LEAK WAS NOTED AT THE UPPER BLUE FITMENT AND SILICONE SEGMENT JUNCTION. THE PATIENT¿S VITAL SIGNS WERE STABLE, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7846798 ↗