Alaris, SmartSite C24103ERecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613203021371), received between Sep 20, 2018 and Dec 17, 2019 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Disconnection” (6 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.

• MalfunctionDec 17, 2019Stretched; Stretched

  IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED TUBING CONCERN. IT WAS NOT KNOWN IF THE EVENT OCCURRED DURING INFUSION OR PRIMING OF THE IV SET. THE CUSTOMER PROVIDED A PHOTO OF THE IV TUBING. ALTHOUGH REQUESTED, THERE IS NO FURTHER PATIENT OR EVENT INFORMATION AVAILABLE.

  Patient problems: No Information

  MAUDE report 9480918 ↗
• MalfunctionApr 4, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT AN UNINTENDED DISCONNECTION OF THE PUMP TUBING TO THE CHILD'S IV ACCESS DEVICE OCCURRED DESPITE THOROUGHLY TIGHTENING THE TUBING. THE NURSE STATED THAT THE PERIPHERAL CATHETERS ARE OFTEN PLACED IN THE CREASE OF THE LEG WHERE THE UPPER LEG MEETS THE GROIN/UPPER ABDOMEN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8483518 ↗
• MalfunctionApr 4, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT DURING A CHILD¿S INFUSION WITH TWO MEDICATIONS AND TWO PUMP MODULES, THE SODIUM CHLORIDE SET DISCONNECTED AT THE LUER CONNECTION TO THE MILRINONE SET. THE EVENT SET WAS CONNECTED TO THE MILRINONE SET LUER CLOSEST TO THE PATIENT'S IV CATHETER. THE EVENT SET INFUSED MAINTENANCE FLUID (500 ML BAG OF 0.45% SODIUM CHLORIDE) AT AN UNKNOWN RATE. THE SET ATTACHED TO THE IV CATHETER CONTAINED MILRINONE (100 ML BAG INFUSING AT 1.82 ML/HR). THE CLINICIAN STATED THAT NO INFECTION OR PATIENT HARM OCCURRED AS A RESULT OF THE DISCONNECTION, AND THE SETS WERE SEQUESTERED FOR INVESTIGATION. ALTHOUGH REQUESTED, NO OTHER EVENT OR PATIENT DETAILS WERE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8483381 ↗
• MalfunctionApr 4, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT DURING A MILRINONE INFUSION (100 ML BAG INFUSING AT 1.82 ML/HR), AN UNINTENDED DISCONNECTION OF THE PUMP TUBING TO THE CHILD'S IV ACCESS DEVICE OCCURRED DESPITE THOROUGHLY TIGHTENING THE TUBING PRIOR TO THE START OF THE INFUSION. THE NURSE STATED THAT THE PERIPHERAL CATHETERS ARE OFTEN PLACED IN THE CREASE OF THE LEG WHERE THE UPPER LEG MEETS THE GROIN/UPPER ABDOMEN. NO PATIENT HARM WAS REPORTED. ALSO CONNECTED TO THE PATIENT AT THE DISTAL Y-SITE CLOSEST TO THE PATIENT'S CATHETER WAS AN ADDITIONAL PRIMARY ADMINISTRATION SET INFUSING A 500 ML BAG OF 0.45% SODIUM CHLORIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8483066 ↗
• MalfunctionApr 4, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT AN UNINTENDED DISCONNECTION OF THE PUMP TUBING TO THE CHILD'S IV ACCESS DEVICE OCCURRED DESPITE THOROUGHLY TIGHTENING THE TUBING. THE NURSE STATED THAT THE PERIPHERAL CATHETERS ARE OFTEN PLACED IN THE CREASE OF THE LEG WHERE THE UPPER LEG MEETS THE GROIN/UPPER ABDOMEN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8482918 ↗
• MalfunctionApr 3, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT AN UNINTENDED DISCONNECTION OF THE PUMP TUBING TO THE CHILD'S IV ACCESS DEVICE OCCURRED DESPITE THOROUGHLY TIGHTENING THE TUBING. THE NURSE STATED THAT THE PERIPHERAL CATHETERS ARE OFTEN PLACED IN THE CREASE OF THE LEG WHERE THE UPPER LEG MEETS THE GROIN/UPPER ABDOMEN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8481052 ↗
• MalfunctionApr 3, 2019Disconnection; Disconnection

  THE CUSTOMER REPORTED UNINTENDED DISCONNECTION OCCURRED DESPITE THOROUGHLY TIGHTENING THE TUBING. THE DISCONNECTION WAS BETWEEN THE SECONDARY SET AND THE UPPER Y SITE OF THE PRIMARY TUBING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8480819 ↗
• MalfunctionOct 24, 2018Crack; Crack

  THE CUSTOMER REPORTED THAT THE MALE LUER CRACKED AT THE CONNECTION TO THE MICROCLAVE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8001356 ↗
• InjurySep 20, 2018Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE TUBING BROKE OFF AT A CONNECTION POINT AND DRIPPED BLOOD WHILE IT WAS CONNECTED TO A PATIENT FOR NO MORE THAN 24 HOURS. THE PATIENT EXPERIENCED A SMALL AMOUNT OF BLOOD LOSS AS THE LINE BACKED UP ONTO THE PATIENT'S BED. THE PATIENT WAS ALREADY RECEIVING DAILY BLOOD WORK. THE BLOOD WORK WAS DONE 6 HOURS EARLIER THAN ITS USUAL TIME. (B)(6) 06:55 AM HGB: 92, (B)(6) 00:23 AM HGB: 88. THERE WAS NO WRITTEN INDICATION IN THE PATIENT'S CHART THAT THIS DROP IN HGB WAS FROM THE BLOOD LOSS DUE TO THE LINE DISCONNECTION. THE TUBING WAS REPLACED AND NO LASTING HARM WAS REPORTED.

  Patient problems: No Code Available

  MAUDE report 7894438 ↗