Alaris, Signature Edition, SmartSite 72023ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613203010276), received between Jun 17, 2020 and Mar 17, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2021Leak/Splash; Free or Unrestricted Flow; Leak/Splash; Free or Unrestricted Flow

  IT WAS REPORTED THAT SE W/CV & 2 VLV PORTS 20 DRP TUBING WAS DAMAGED, LEAKED, AND HAD AIR IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2021 VHIMS #158229. PT WAS RECEIVING IV LIPIDS, SMALL CRACK NOTICED IN LINE LIPIDS LEAKING OUT OF LINE AND SMALL AMOUNTS OF AIR ENTERING LINE. LINE CHANGED AND DR INFORMED. MEDICAL STAFF CONSIDERING PROPHYLACTIC IVABS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11509871 ↗
• MalfunctionMar 17, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SE W/CV & 2 VLV PORTS 20 DRP TUBING WAS DAMAGED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NICU REPORTED ON THE(B)(6)2021 VHIMS #158393 O ¿PATIENT HAD LOW BSL ON ABGS FROM 0600HRS (B)(6) THROUGHOUT THE DAY. AT 1515HRS (B)(6)NOTED PUDDLE OF TPN BELOW ALARIS PUMP AND LEAKING FROM BOTTOM OF THE CLASP (CONNECTED TO THE LINE) THAT INSERTS INTO THE ALARIS PUMP. PHOTOS OF PUDDLE AND LINE IN MEDIA ON PATIENTS EMR¿. O PATIENT ON NUTRIENT (NOT LIPID). O LOT NUMBER NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11509869 ↗
• MalfunctionMar 17, 2021Backflow; Leak/Splash; Backflow; Leak/Splash

  IT WAS REPORTED THAT SE W/CV & 2 VLV PORTS 20 DRP TUBING WAS DAMAGED, LEAKED, AND HAD AIR IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2021 VHIMS #(B)(4). ¿COMMENCED REPLACEMENT FLUID. NOTED AT 2 HOURS INTO ADMINISTRATION THAT THERE WAS A SMALL WET PATCH ON THE UNDER PUMP. EXAMINED THE LINE AS PREVIOUS DAY HAD ISSUES AND NOTED A CRACK TO THE MIDDLE OF THE GIVING SET WHICH WAS PLACED INTO THE PUMP. CRACK NOT PRESENT DURING ADMINISTRATION INTO THE PUMP, CHECKED BY MYSELF AS PREVIOUS DAY HAD ISSUES WITH GIVING SET IN SIMILAR MANNER.¿ IV MAINTENANCE NOTED ON VHIMS TO BE SODIUM CHLORIDE AND POTASSIUM CHLORIDE. LIPID HAS BACKFLOWED UP IV LINE FROM THE PATIENT END TO THE LOWER SMARTSITE (NOT SURE IF THE LIPID WAS CONNECTED AT THE LOWER SMART SITE, OR AT THE END OF THE IV LINE). O IV PACKAGE RETURNED WITH IV LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11509868 ↗
• MalfunctionMar 17, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SE W/CV & 2 VLV PORTS 20 DRP TUBING WAS DAMAGED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION ON (B)(6) 2021, NUTRIENT LINE CRACKED, NOTED TO BE LEAKING BY MOTHER, FOUND CRACK IN THE LINE WHERE THE LATCH SITS. LOT NUMBER NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11509529 ↗
• MalfunctionAug 31, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SE W/CV & 2 VLV PORTS 20 DRP WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REPORTED FEEDBACK SUGGESTS THAT THERE IS A CRACKED ALARIS SE IV LINE.

  Patient problems: No Patient Involvement

  MAUDE report 10471263 ↗
• MalfunctionJun 17, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 4 SE W/CV & 2 VLV PORTS 20 DRP WERE CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PUMP UPSTREAM OCCLUSION CAUSED BY GIVING SET. CPA MENTIONED ON THE PHONE THAT SINCE TRANSITIONING BACK TO 72023E THERE HAS BEEN AN INCREASED NUMBER OF UPSTREAM OCCLUSIONS. THIS PROBLEM HAD STOPPED OCCURING WHEN THEY WERE USING 72013EB ONLY BUT HAS RE-EMERGED NOW THEY ARE BACK TO USING 72023E. SOMETIMES THIS RESULTS IN THE PUMP BEING SEND TO BIOMEDICAL ENGINEERING AS THE NURSE PERSIVES IT TO BE A PUMP FAULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10165817 ↗