NaturaLyte 08-1301-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840861101665), received between Dec 2, 2020 and Dec 2, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Chemical Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED A LOT OF NATURALYTE WHICH WAS RESULTING IN LOW CONDUCTIVITY VALUES DURING SETUP. UPON FOLLOW UP, THE BIOMED REPORTED THAT DURING SETUP OF THE HD MACHINE, THE THEORETICAL CONDUCTIVITY (TCD) WAS SET AT 14.0 MS/CM AND THE REPORTED LOT OF NATURALYTE HAD AN ACTUAL CONDUCTIVITY OF 13.6 MS/CM. NO PATIENTS WERE TREATED WITH THE LOT. PER THE BIOMED, THERE WAS NO SERVICE TO THE MACHINES AND THEY USE BICARBONATE NATURALYTE (UNKNOWN LOT NUMBER). NO SAMPLES OF THE NATURALYTE WERE RETURNED.

  Patient problems: No Patient Involvement

  MAUDE report 10932685 ↗