Alaris, SmartSite 10015489Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613203021050), received between Aug 17, 2018 and Aug 18, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2020Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT GEM 20DP 3SS CKV DEHP FREE HAD AIR IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REPORTED FEEDBACK SUGGESTS THAT THERE IS AIR IN LINE. ATTEMPTED TO SET UP AN IV INFUSION AND AFTER PRIMING THE GIVING SET GOT A CONSISTENT AIR IN LINE ALARM THROUGH THE PUMP. NO AIR IN LINE SEEN. CHANGED THE CHANNEL AND THE ALARM CONTINUED. CHANGED THE BRAIN AND THE ALARM WAS ONGOING. CHANGED THE REPLACEMENT GIVING SET AND ALARM IMMEDIATELY RECTIFIED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10421020 ↗
• MalfunctionFeb 10, 2020Material Separation; Material Separation

  THE REPORTED FEEDBACK SUGGESTS THAT THE LINE FELL APART. FROM THE REPORTED INFORMATION THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9688465 ↗
• MalfunctionApr 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED FLUID WAS INFUSING, AFTER 20 MLS VOLUME INFUSED ,THE USER NOTICED A LEAK AT AN UNKNOWN LOCATION. THE USER CHANGED OUT THE SET WITH THE SAME LOT AND HAD NO FURTHER ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527439 ↗
• MalfunctionMar 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A DOXORUBICIN (117MG) INFUSION AT AN UNSPECIFIED RATE, A LEAK AT THE MALE LUER WAS NOTED LEAKING CHEMO ONTO THE PATIENT AT AN UNDISCLOSED AREAS. THERE WAS NO INDICATION OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8448616 ↗
• MalfunctionMar 25, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT DURING AN AZACITIDINE (200 MG) INFUSION AT AN UNSPECIFIED RATE, THE DEVICE ALARMED. UPON FURTHER EXAMINATION THE SET SEPARATED AND LEAKED AT THE MALE LUER. IT WAS REPORTED THAT THE CHEMO LEAK DID NOT REACH THE PATIENT SKIN. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8448367 ↗
• MalfunctionMar 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A CISPLATIN (172 MG) INFUSION AT AN UNSPECIFIED RATE, THE DEVICE ALARMED. UPON FURTHER EXAMINATION A LEAK WAS NOTED AT THE SAFETY CLAMP OF THE PRIMARY TUBING. IT WAS REPORTED THAT THE CHEMO LEAK DID NOT REACH THE PATIENT SKIN. THERE WAS NO REPORT OF PATIENT HARM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8448303 ↗
• MalfunctionAug 17, 2018Stretched; Stretched

  THE REPORTED FEEDBACK SUGGESTS THAT DURING A VANCOMYCIN INFUSION THE CLINICIAN OPENED THE PUMP'S DOOR AND NOTICED A BULGED PUMPING SEGMENT.. FROM THE REPORTED INFORMATION THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7795149 ↗