Alaris, SmartSite C25004ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403235580), received between Mar 12, 2019 and Mar 13, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN ANEMIC ICU PATIENT REQUIRING MULTIPLE TRANSFUSIONS WAS TRANSFERRED TO RADIOLOGY FOR AN MRI PROCEDURE. THE PATIENT WAS TRANSPORTED WITH A LONG AND SHORT EXTENSION SET PRIMED WITH HEPARIN (50/UNITS/ML /25,000U/ 500ML) AT AN UNSPECIFIED RATE, WHILE THE INFUSION DEVICES REMAINED OUTSIDE THE MRI SUITE. WITHIN 30 MINUTES OF CONNECTION TO THE EXTENSION SETS, BLOOD BACKED UP THE LINE AND LEAKED ONTO THE FLOOR, CREATING AN APPROXIMATELY 30 INCH POOL OF BLOOD. IT WAS SUBSEQUENTLY REPORTED THAT THE PATIENT LATER REQUIRED A UNIT OF BLOOD THAT SAME DAY; POSSIBLY FROM THE VOLUME OF BLOOD LOSS FROM THE EVENT. ALTHOUGH REQUESTED, NO FURTHER DETAILS OR INFORMATION WAS PROVIDED REGARDING THIS EVENT, AND NO INFORMATION WAS RECEIVED AS TO THE RECOVERY OF THE PATIENT.

  Patient problems: Anemia; Blood Loss

  MAUDE report 8416790 ↗
• InjuryMar 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PROPOFOL INFUSION LEAKED WHILE IN THE MRI SUITE OF RADIOLOGY FOR A PROCEDURE. THE ICU PATIENT WAS TRANSPORTED TO RADIOLOGY WITH A LONG AND SHORT EXTENSION SET PRIMED WITH PROPOFOL AT AN UNSPECIFIED RATE FOR SEDATION, WHILE THE INFUSION DEVICES REMAINED OUTSIDE THE MRI. WITHIN 1 HOUR OF ATTACHING THE EXTENSION SETS, THE PATIENT BECAME INCREASINGLY AGITATED WHILE ON THE MRI TABLE , AND THE USER NOTICED A LARGE WET AREA ON THE SHEETS LEAKING PROPOFOL. THE PATIENT REQUIRED AN ADDITIONAL DOSE OF SEDATIVE (PROPOFOL ) TO PREVENT THE PATIENT FROM REMOVING THE ENDOTRACHEAL TUBE. ALTHOUGH REQUESTED, NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER FOR THIS EVENT.

  Patient problems: Anxiety

  MAUDE report 8412879 ↗