NaturaLyte 08-4231-0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840861101801), received between Oct 12, 2017 and Nov 30, 2020 — classified as 1 death, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 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 DURING SETUP, THE CONDUCTIVITY WAS AT 13.2MS/CM. THE THEORETICAL CONDUCTIVITY VALUE (TCD) SETTING ON THE MACHINE WAS NOT PROVIDED AND THE DIFFERENCE BETWEEN ACTUAL CONDUCTIVITY IS UNKNOWN. NO PATIENTS WERE TREATED WITH THE LOT. PER THE BIOMED, 2 JUGS WERE AFFECTED AND THEY HAD 6 JUGS TOTAL. THE BIOMED REPORTED THAT THERE WAS NO SERVICE TO THE MACHINES AND THAT THEY USE BICARBONATE RX12. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Patient Involvement

  MAUDE report 10924428 ↗
• DeathOct 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BIOMEDICAL ENGINEER (BIOMED TECH) REPORTED AN ADVERSE EVENT OCCURRED DURING HEMODIALYSIS TREATMENT ON (B)(6) 2017. ADDITIONAL FOLLOW-UP REVEALED A PATIENT EXPIRED WHILE DIALYZING. PER BIOMED TECH THE MACHINE DID NOT HAVE ANY ISSUES DURING SET-UP AND THAT THE MACHINE DID NOT ALARM AT THE TIME THE PATIENT EXPIRED. (B)(6) STATED NO MACHINE REPAIRS WERE NEEDED AND THE MACHINE WAS PLACED BACK IN SERVICE. THE BIOMED TECH STATED THE FACILITY ALSO USED FRESENIUS 2008T HEMODIALYSIS MACHINES, FRESENIUS DIALYZERS, BLOODLINES, ACID CONCENTRATE DELIVERED VIA JUGS. ADDITIONAL FOLLOW-UP WAS MADE WITH THE CLINIC MANAGER, WHO REVEALED THE PATIENT EXPIRED WHEN HE WAS NEAR THE END OF HEMODIALYSIS TREATMENT AT THE BEGINNING OF THE RINSE BACK PROCESS. THE CLINIC MANAGER DECLINED TO HAVE A FRESENIUS RES COME OUT FOR MACHINE EVALUATION. THE CLINIC MANAGER STATED THE PATIENT¿S CAUSE OF DEATH WAS CARDIAC ARREST, AND INDICATED THE PATIENT HAD PRE-EXISTING CARDIAC RELATED ISSUES AS WELL AS METASTATIC CANCER. THE CLINIC MANAGER STATED THE PATIENT WAS HOSPITALIZED THE WEEK PRIOR DUE TO CARDIAC RELATED ISSUES, AND INDICATED THE PATIENT BEGAN HIS FIRST HEMODIALYSIS TREATMENT WHILE HOSPITALIZED ON (B)(6) 2017,

  Patient problems: Cardiac Arrest; Death; Seizures

  MAUDE report 6944990 ↗