NaturaLyte 08-1251-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00840861101658), received between May 24, 2019 and Dec 2, 2020 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 14, 2026Class IIOpen, Classified

   Complaints of blue-green discoloration in product

   Z-3092-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 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 THAT A BATCH OF NATURALYTE HAD LOW CONDUCTIVITY VALUES DURING TREATMENT. UPON FOLLOW UP, THE BIOMED REPORTED THAT THE CONDUCTIVITY WAS AT 12.9 MS/CM. THE BIOMED REPORTED THAT THE PATIENT COMPLETED TREATMENT WITH THIS PRODUCT. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. PER BIOMED 15 CASES WERE AFFECTED, AND THEY ARE USING NATURALYTE LOT NUMBER 20LTAC081 WITHOUT ANY ISSUES. THE BIOMED REPORTED THAT THERE HAS NOT BEEN ANY SERVICE OF REPAIRS TO THE MACHINES AND THEY USE NATURALYTE 45X BICARBONATE LOT NUMBER 20KTBC004. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC TO RETURN A SAMPLE FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10932840 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A BATCH OF NATURALYTE HAD LOW CONDUCTIVITY VALUES DURING TREATMENT. UPON FOLLOW UP, THE BIOMED REPORTED THAT THE CONDUCTIVITY WAS AT 12.9 MS/CM. THE BIOMED REPORTED THAT THE PATIENT COMPLETED TREATMENT WITH THIS PRODUCT. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. PER BIOMED 15 CASES WERE AFFECTED, AND THEY ARE USING NATURALYTE LOT NUMBER 20LTAC081 WITHOUT ANY ISSUES. THE BIOMED REPORTED THAT THERE HAS NOT BEEN ANY SERVICE OF REPAIRS TO THE MACHINES AND THEY USE NATURALYTE 45X BICARBONATE LOT NUMBER 20KTBC004. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC TO RETURN A SAMPLE FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10932761 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FRESENIUS FIELD SERVICE TECHNICIAN (FST) REPORTED ON BEHALF OF A (B)(6) CLINIC THAT A BATCH OF NATURALYTE WAS RESULTING IN LOW CONDUCTIVITY DURING TESTING/SET-UP PRIOR TO INITIATING TREATMENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NO RESPONSES HAVE BEEN RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 10931969 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FRESENIUS FIELD SERVICE TECHNICIAN (FST) REPORTED ON BEHALF OF A HEMODIALYSIS CLINIC THAT A BATCH OF NATURALYTE WAS RESULTING IN LOW CONDUCTIVITY DURING TESTING/SET-UP PRIOR TO INITIATING TREATMENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NO RESPONSES HAVE BEEN RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 10931963 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FRESENIUS FIELD SERVICE TECHNICIAN (FST) REPORTED ON BEHALF OF A HEMODIALYSIS (HD) CLINIC THAT A BATCH OF NATURALYTE WAS RESULTING IN LOW CONDUCTIVITY DURING TESTING/SET-UP PRIOR TO INITIATING TREATMENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NO RESPONSES HAVE BEEN RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 10931957 ↗
• 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. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, ADVERSE EVENT, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 10929789 ↗
• MalfunctionNov 27, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY DURING TESTING/SET-UP PRIOR TO INITIATING TREATMENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. UPON FOLLOW UP, THE BMT REPORTED DURING SETUP THE CONDUCTIVITY WAS AT 13.1 MS/CM AND THE THEORETICAL CONDUCTIVITY VALUE (TCD) WAS SET TO 13.6 MS/CM. HE CONFIRMED NO PATIENTS WERE TREATED WITH THIS BATCH. THERE WAS NO RECENT SERVICE TO THE MACHINE. THERE WERE A TOTAL OF 6 CASES OF THIS REPORTED LOT. THE BMT HAS NOT BEEN IN CONTACT WITH CUSTOMER SERVICE TO RETURN THE ALLEGED PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10913648 ↗
• MalfunctionNov 25, 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 BEFORE USE, THE CONDUCTIVITY WAS AT 13.1. NO PATIENTS WERE TREATED WITH THE LOT. PER THE BIOMED, 6 CASES ARE EFFECTED AND NOW THEY ARE USING NATURALYTE LOTS 20NTAC025, 20LTAC053, AND 20LTAC039. THE BIOMED REPORTED THAT THERE WAS NO SERVICE TO THE MACHINES AND THAT THEY USE BICARBONATE NATURALYTE 45X, LOT NUMBER 20NTBC001. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Patient Involvement

  MAUDE report 10906093 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 05/15/2019 A BIOMEDICAL (BIOMED) TECHNICIAN FROM A HEMODIALYSIS (HD) CLINIC REPORTED A CARDIOPULMONARY PATIENT EVENT ON THE MACHINE DURING TREATMENT ON (B)(6) 2019. THE NURSE DREW A DIALYSATE SAMPLE POST EVENT AND THE POTASSIUM (K+) WAS OUT OF RANGE (UNSPECIFIED VALUES). THE BIOMED TOOK A DIALYSATE SAMPLE FROM A DIFFERENT LOT WHICH WAS IN RANGE. ADDITIONAL INFORMATION WAS OBTAINED. THIS MALE PATIENT ON HD THERAPY ARRIVED FOR A 3.5 HOUR HD TREATMENT ON (B)(6) 2019 UTILIZING THE FRESENIUS 2008K2 MACHINE AND NATURALYTE (LIQUID ACID CONCENTRATE FOR BICARBONATE HEMODIALYSIS) 1251, 1K, 2.5 CA, 1MG. WHEN TREATMENT WAS COMPLETED, THE PATIENT EXPERIENCED A SEIZURE. PRIOR TO THE EVENT THE PATIENT¿S BLOOD PRESSURE (BP) WAS LOW (UNKNOWN VALUE) DURING THE TREATMENT (TIME UNSPECIFIED). BP WAS MONITORED BUT NO MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL FLUID VOLUME REPLACEMENT WAS PROVIDED ASIDE FROM THE STANDARD 400ML NORMAL SALINE FOR SYSTEM RETURN. THE PATIENT WAS PUT ON O2 VIA NASAL CANNULA AT 2L RATE. THE PATIENT BECAME UNRESPONSIVE, 911 WAS CALLED, AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. AFTER APPROXIMATELY 30 SECONDS (1 ROUND OF COMPRESSIONS) THE PATIENT RESPONDED.

  Patient problems: Cardiopulmonary Arrest; Low Blood Pressure/ Hypotension; Seizures

  MAUDE report 8640848 ↗