NaturaLyte 08-3301-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840861101757), received between Nov 25, 2020 and Dec 2, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (6 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 14, 2026Open, Classified

   Complaints of blue-green discoloration in product

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

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A NATURALYTE LOT HAD LOW CONDUCTIVITY VALUES WHILE TESTING ON AN HD MACHINE. UPON FOLLOW UP, THE ATOM CONFIRMED THERE WAS NO PATIENT INVOLVEMENT IN THIS REPORTED EVENT. THE LOT OF NATURALYTE HAD A CONDUCTIVITY VALUE OF 13.2 MS/CM. THE THEORETICAL CONDUCTIVITY VALUE PARAMETERS ON THE MACHINE WERE NOT PROVIDED. THE REPORTED BATCH WAS NOT USED ON ANY PATIENT AFTER DISCOVERING THE CONDUCTIVITY ISSUES. THE CLINIC IS CURRENTLY USING NATURALYTE DRY BI-CARB RX12 (LOT NUMBER UNKNOWN). THERE WAS NO RECENT SERVICE PERFORMED ON THE MACHINE. THERE ARE NO SAMPLES EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 10933011 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A BATCH OF NATURALYTE WAS RESULTING IN LOW CONDUCTIVITY DURING TREATMENT. THERE WAS NO REPORTED ADVERSE EVENT, SERIOUS INJURY, NOR REQUIRED MEDICAL INTERVENTION RELATED TO THE EVENT. UPON FOLLOW UP, THE BMT REPORTED DURING TREATMENT THE CONDUCTIVITY WAS BETWEEN .6 AND .7 MS/CM AND BELOW THE THEORETICAL CONDUCTIVITY VALUE (TCD). THE PATIENT WAS UNABLE TO COMPLETE TREATMENT. THERE WAS NO RECENT SERVICE TO THE MACHINE. THERE WERE A TOTAL OF 12 AFFECTED JUGS OF THIS REPORTED LOT. THE BMT HAS NOT BEEN IN CONTACT WITH CUSTOMER SERVICE TO RETURN THE ALLEGED PRODUCT. THEY USE NATURALYTE DRY PACK RX-12 BICARBONATE, LOT NUMBER UNKNOWN. A PICK UP WAS SCHEDULED FOR A SAMPLE OF THE REPORTED BATCH. THE CLINIC UTILIZES RX-12 NATURALYTE DRY BI-CARB OF UNKNOWN LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10932080 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO TECHNICAL SUPPORT A LOW CONDUCTIVITY ALARM CAUSED BY THE NATURALYTE LIQUID CONCENTRATE. UPON FOLLOW UP, THE CUSTOMER SAID THAT DURING TREATMENT, THE CONDUCTIVITY WAS AT 13.3 AND TCD 13.8. THE PATIENT WAS SWITCHED TO ANOTHER LOT MID-TREATMENT WITHOUT ANY ILL EFFECTS OR ADVERSE EVENTS. PER THE BIOMED, THERE HAS NOT BEEN ANY RECENT SERVICE TO THE MACHINE THAT WOULD EFFECT CONDUCTIVITY AND THAT THEY USE BIBAG 400RX12, LOT NUMBER UNKNOWN. THE BIOMED REPORTED THAT THERE ARE 4 CASES AFFECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10927222 ↗
• MalfunctionNov 29, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A THREE BATCHES OF NATURALYTE WERE RESULTING IN 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 13.2 MS/CM ALTHOUGH 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 2 CASES OF EACH REPORTED LOT, HOWEVER, THEY WERE DISCARDED. THE HD CLINIC IS UTILIZING BIBAGS FOR BICARBONATE (UNKNOWN PRODUCT AND LOT NUMBERS).

  Patient problems: No Patient Involvement

  MAUDE report 10916192 ↗
• MalfunctionNov 29, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A THREE BATCHES OF NATURALYTE WERE RESULTING IN 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 13.2 MS/CM ALTHOUGH 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 2 CASES OF EACH REPORTED LOT, HOWEVER, THEY WERE DISCARDED. THE HD CLINIC IS UTILIZING BIBAGS FOR BICARBONATE (UNKNOWN PRODUCT AND LOT NUMBERS).

  Patient problems: No Patient Involvement

  MAUDE report 10916190 ↗
• MalfunctionNov 25, 2020Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO TECHNICAL SUPPORT A LOW CONDUCTIVITY ALARM CAUSED BY THE NATURALYTE LIQUID CONCENTRATE. UPON FOLLOW UP, THE CUSTOMER SAID THAT DURING TREATMENT, THE CONDUCTIVITY WAS AT 13.3 AND TCD 13.8. THE PATIENT WAS SWITCHED TO ANOTHER LOT MID-TREATMENT WITHOUT ANY ILL EFFECTS OR ADVERSE EVENTS. PER THE BIOMED, THERE HAS NOT BEEN ANY RECENT SERVICE TO THE MACHINE THAT WOULD EFFECT CONDUCTIVITY AND THAT THEY USE BIBAG 400RX12, LOT NUMBER UNKNOWN. THE BIOMED REPORTED THAT THERE ARE 4 CASES AFFECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10906096 ↗