NaturaLyte 08-2351-8Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840861101719), received between Dec 1, 2020 and Dec 1, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (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.

• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. UPON FOLLOW UP, THE BIOMED REPORTED THAT THE PROBLEM WAS NOT THE NATURALYTE, BUT RATHER A BATCH OF BICARBONATE. THE BIOMED STATED WHEN THEY STARTED UP FOR THE DAY THE MACHINES WERE GETTING LOW CONDUCTIVITY. THE BIOMED STATED THEY CHECKED THE BICARBONATE AND FOUND THAT THE VALUES WERE NOT CORRECT. THE BICARBONATE WAS DISCARDED. THE BIOMED STATED THEY REMIXED THE BICARBONATE TO RESOLVE THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 10928382 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. THE BIOMED REPORTED THAT THE CONDUCTIVITY WOULD NOT GO ABOVE 13.0MS/CM. THE THEORETICAL CONDUCTIVITY VALUE (TCD) SETTING ON THE MACHINE WAS NOT PROVIDED AND THE DIFFERENCE BETWEEN ACTUAL CONDUCTIVITY IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER TO DATE HAS NOT BEEN PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10925861 ↗