Alaris, SmartSite 10821753Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613203019187), received between Aug 19, 2019 and Jul 21, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

2 FDA recall records name this device's identifier, 2 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. Aug 19, 2026Class IOpen, Classified

   Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.

   Z-3080-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Oct 11, 2023Class IIOpen, Classified

   Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

   Z-0349-2024 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2020Leak/Splash; Improper Flow or Infusion; Leak/Splash; Improper Flow or Infusion

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF GEM V/NV MC 4SS 20DP 10PK DEHP FREE EXPERIENCED A MISSING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR SURGICAL SERVICES DEPT ENCOUNTERED AN ISSUE WITH THE BURRETTE SET WHERE THE WHITE CLAMP WAS MISSING.

  Patient problems: No Patient Involvement

  MAUDE report 10304770 ↗
• MalfunctionJul 6, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AS LVP BUR 20D 3SS LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10821753, BATCH(LOT) NO: 20026322. IT WAS REPORTED THAT DURING AN UNSPECIFIED INFUSION THERAPY, LEAKAGE WERE OBSERVED ON THE BURETTE SET AND 0.2 MICRON FILTER EXTENSION SET. THE INFUSION CONTINUED AND COMPLETED THE THERAPY. THERE WAS NO PATIENT HARM AND THE LEAK DID NOT CAUSE HARM TO THE HEALTHCARE PROVIDER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10237663 ↗
• MalfunctionJun 26, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AS LVP BUR 20D 3SS LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DURING AN UNSPECIFIED INFUSION THERAPY, LEAKAGE WERE OBSERVED ON THE BURETTE SET AND 0.2 MICRON FILTER EXTENSION SET. THE INFUSION CONTINUED AND COMPLETED THE THERAPY. THERE WAS NO PATIENT HARM AND THE LEAK DID NOT CAUSE HARM TO THE HEALTHCARE PROVIDER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10203611 ↗
• MalfunctionJun 18, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN UNSPECIFIED INFUSION THERAPY, LEAKAGE WERE OBSERVED ON THE BURETTE SET AND 0.2 MICRON FILTER EXTENSION SET. THE INFUSION CONTINUED AND COMPLETED THE THERAPY. THERE WAS NO PATIENT HARM AND THE LEAK DID NOT CAUSE HARM TO THE HEALTHCARE PROVIDER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10171984 ↗
• MalfunctionAug 19, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE BURETTE SEPARATED AND LEAKED FROM THE TUBING SET WHERE THE SPIKE ENTERS THE TOP OF THE BURETTE WHEN THE NURSE MOVED THE IV FROM THE STRETCHER TO AN IV POLE. THE TUBING SET WAS QUICKLY REPLACED. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PEDIATRIC PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8908047 ↗