NaturaLyte 13-3251-9Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840861101887), received between Nov 30, 2020 and Dec 2, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY HAD A NATURALYTE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES ON AN UNSPECIFIED NUMBER OF HD MACHINES. UPON FOLLOW UP THE REGISTERED NURSE (RN) CONFIRMED THE REPORTED EVENT. SHE CLARIFIED THAT THE OCCURRENCE DATES ARE UNKNOWN. SHE CONFIRMED THAT IN ALL CASES WHERE THEY EXPERIENCED CONDUCTIVITY ISSUES DURING TREATMENT, ALL THE PATIENTS WERE ABLE TO COMPLETE THEIR TREATMENT AFTER SWITCHING THE JUGS OF NATURALYTE MID-TREATMENT. THERE WERE NO ADVERSE EVENTS, SERIOUS INJURIES, NOR REQUIRED MEDICAL INTERVENTION AS A RESULT OF THESE EVENTS. THEY ARE CURRENTLY USING BIBAGS BI-CARB. SAMPLE RETURN PICKUP WAS SCHEDULED. THIS RECORD CAPTURES ALL OF THE CLINIC¿S UNSPECIFIED NUMBER OF INCIDENTS OF LOW CONDUCTIVITY EXPERIENCED DURING TREATMENT WHILE UTILIZING THE REPORTED BATCH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10933143 ↗
• MalfunctionNov 30, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY HAD TWO NATURALYTE BATCHES THAT HAD LOW CONDUCTIVITY VALUES DURING SETUP PRIOR TO HD TREATMENT. UPON FOLLOW UP THE REGISTERED NURSE (RN) CONFIRMED THE REPORTED EVENT. SHE INDICATED THEY HAVE CONTINUED TO USE THE AFFECTED BATCHES AFTER RECEIVING AN GUIDANCE ON PRESCRIPTION, AND SETTING CHANGES THAT WILL AVOID THE CONDUCTIVITY ISSUES. THEY ARE CURRENTLY USING BIBAGS BI-CARB. SAMPLE RETURN PICKUP WAS SCHEDULED. THEY EXPERIENCED LOW CONDUCTIVITY DURING SETUP AN UNSPECIFIED NUMBER OF TIMES AND ON UNKNOWN DATES. THIS RECORD CAPTURES ALL OF THE CLINIC¿S INCIDENTS OF LOW CONDUCTIVITY EXPERIENCED DURING SETUP WHILE UTILIZING THE REPORTED BATCH.

  Patient problems: No Patient Involvement

  MAUDE report 10919444 ↗