NaturaLyte 08-4000-LB 6.4LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840861101931), received between Aug 11, 2017 and Aug 11, 2017 — classified as 1 death.

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

• DeathAug 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED CARDIAC ARREST AND SEPTIC SHOCK, AND ULTIMATELY EXPIRED ON (B)(6) 2014, WHICH IS ALLEGED TO HAVE BEEN DUE TO THE USE OF THE NATURALYTE LIQUID BICARBONATE CONCENTRATE PRODUCT. THE PLAINTIFF'S ATTORNEY REPORTED THAT THE DECEDENT WAS EXPOSED TO NATURALYTE PRODUCT THAT WAS CONTAMINATED WITH BACTERIA DURING THEIR HEMODIALYSIS (HD) TREATMENT.

  Patient problems: Cardiac Arrest; Death; Septic Shock

  MAUDE report 6788515 ↗