NaturaLyte 08-3231-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840861101733), received between Nov 26, 2020 and Feb 15, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2021Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT ONE OF THE ACID CONCENTRATES (CATALOG # 08-3231-1, LOT # 20LXAC090) HE USES HAS BEEN MANUFACTURED WITH A LOWER SODIUM CONCENTRATION. HE STATED HE IS HAVING DIFFICULTY ADJUSTING THE CONDUCTIVITY ALARM LIMITS SO THAT IT WILL NOT ALARM. TECHNICAL SUPPORT EXPLAINED THAT THE CONCENTRATE IS NOT TO BE USED AND EMAILED FORM FA-2020-41-X RECALL AND FA-2021-02-D, WHICH STATES NOT TO USE IT AND THE AFFECTED LOT NUMBERS. THERE WAS NO PATIENT INVOLVEMENT, NO HARM OR ADVERSE EVENT REPORTED AS THE ISSUE OCCURRED PRIOR TO TREATMENT. DURING FOLLOW UP, THE BMT CONFIRMED THE EVENT OCCURRED PRIOR TO TREATMENT. HE INDICATED THIS LOT NEVER HAD CONDUCTIVITY ISSUES BEFORE. THERE ARE NO SAMPLES OF THE REPORTED LOT AVAILABLE TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11327738 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY VALUES DURING SETUP AND PRIOR TO TREATMENT. UPON FOLLOW UP, THE BIOMED REPORTED THAT BEFORE USE, THE CONDUCTIVITY WAS AT 13.3 MS/CM AND BELOW THE THEORETICAL CONDUCTIVITY VALUE SETTING ON THE MACHINE. NO PATIENTS WERE TREATED WITH THE LOT. PER THE BIOMED, 15 CASES WERE AFFECTED AND THE LOT NUMBER FOR THE NATURALYTE THEY WERE CURRENTLY USING WAS NOT PROVIDED. THE BIOMED REPORTED THAT THERE HAS BEEN NO SERVICE TO THE MACHINES AND THAT THEY USE BICARBONATE NATURALYTE RX12, LOT NUMBER UNKNOWN. NO SAMPLE WAS RETURNED FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 10932784 ↗
• 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 DURING A PATIENT¿S TREATMENT, THE CONDUCTIVITY WAS AT 13.1 MS/CM AND FLUCTUATING. THE THEORETICAL CONDUCTIVITY VALUE (TCD) SETTING ON THE MACHINE WAS NOT PROVIDED AND THE DIFFERENCE BETWEEN ACTUAL CONDUCTIVITY IS UNKNOWN. THE PATIENT COMPLETED TREATMENT ON THE MACHINE WITH THE SAME JUG OF NATURALYTE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. PER THE BIOMED, THEY USED OTHER JUGS FROM THE SAME LOT WITHOUT ANY ISSUES. THE BIOMED REPORTED THAT THERE WAS NO SERVICE TO THE MACHINES AND THAT THEY USE BICARBONATE 4000RX. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10925770 ↗
• MalfunctionNov 26, 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 WAS AT 13.1. NO PATIENTS WERE TREATED WITH THE LOT, HOWEVER ONE PATIENT¿S TREATMENT WAS DELAYED BY 15 MINUTES. NO HARM OCCURRED TO THE PATIENT. PER THE BIOMED, TWO CASES ARE EFFECTED AND NOW THEY ARE USING AN UNKNOWN BATCH OF NATURALYTE. THE BIOMED REPORTED THAT THERE WAS NO SERVICE TO THE MACHINES. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Patient Involvement

  MAUDE report 10908495 ↗