NaturaLyte 13-2251-0Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840861101863), received between Apr 3, 2018 and Dec 2, 2020 — classified as 2 injuries, 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A HEMODIALYSIS (HD) CLINIC EXPERIENCED LOW CONDUCTIVITY WITH A BATCH OF NATURALYTE 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 AT 13.1 MS/CM ALTHOUGH THE THEORETICAL CONDUCTIVITY VALUE (TCD) WAS SET TO 13.5. THE NATURALYTE JUG WAS SWITCHED OUT MID-TREATMENT WITHOUT ANY ILL EFFECTS. THERE WAS NO RECENT SERVICE PERFORMED ON THE MACHINE. THE BMT DUMPED OUT TWO 55 GALLON DRUMS OF THE SAME BATCH. NO SAMPLES ARE AVAILABLE TO RETURN. THEY ARE CURRENTLY USING GRANUFLO AND BIBAGS 4000RX 12 (UNKNOWN PART AND LOT NUMBERS).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10933149 ↗
• MalfunctionNov 29, 2020Chemical Problem; Chemical Problem

  A BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A HEMODIALYSIS (HD) CLINIC EXPERIENCED LOW CONDUCTIVITY WITH TWO BATCHES OF NATURALYTE DURING TESTING/SET-UP PRIOR TO INITIATING TREATMENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. UPON FOLLOW UP, THE BMT REPORTED DURING TESTING THE CONDUCTIVITY FOR BATCHES 20LXAC021 AND 20LXAC079 WAS AT 13.1 MS/CM ALTHOUGH THE THEORETICAL CONDUCTIVITY VALUE (TCD) WAS SET TO 13.5 MS/CM. FOR BATCH 20LXAC021 THERE WAS 1 DRUM AFFECTED AND FOR BATCH 20LXAC079 THERE WAS 1 CASE AFFECTED. NO SAMPLES ARE AVAILABLE TO RETURN. THE BMT CONFIRMED THE BATCH WAS NOT USED FOR ANY PATIENT TREATMENTS. THEY ARE CURRENTLY USING GRANUFLO AND BIBAGS 4000RX 12 (UNKNOWN PART AND LOT NUMBERS). THERE WAS NO RECENT SERVICE TO THE MACHINE.

  Patient problems: No Patient Involvement

  MAUDE report 10916195 ↗
• MalfunctionDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY DIALYSIS TECHNICIAN (DT) REPORTED THAT A PATIENT ON HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY (RRT) WAS FEELING UNWELL DURING THEIR HD TREATMENT ON (B)(6) 2018. UPON FOLLOW UP, THE DT STATED THAT 30 MINUTES AFTER THE INITIATION OF THEIR TREATMENT, THE PATIENT REPORTED FEELING UNWELL. APPROXIMATELY 10-15 MINUTES LATER, THE PATIENT WAS DIAPHORETIC, VOMITING, AND NAUSEOUS. THE PATIENT WAS MOVED TO A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THERE WAS NO MEDICAL INTERVENTION NECESSARY DURING THE REPORTED EVENT AND THERE WAS NO SERIOUS INJURY TO THE PATIENT. ADDITIONAL PATIENT, INTERVENTION, EVENT, AND HOSPITALIZATION DETAILS WERE REQUESTED, BUT WERE NOT PROVIDED.

  Patient problems: Diaphoresis; Nausea; Vomiting

  MAUDE report 8189321 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY DIALYSIS TECHNICIAN (DT) REPORTED THAT A PATIENT ON HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY (RRT) WAS FOUND UNRESPONSIVE DURING THEIR HD TREATMENT ON (B)(6) 2018. UPON FOLLOW UP, THE DT STATED THAT 1.5 HOURS AFTER THE INITIATION OF THEIR TREATMENT, THE PATIENT WAS FOUND UNRESPONSIVE. EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM (ER). THE DT STATED THAT HEMATOLOGICAL STUDIES CONDUCTED IN THE ER REVEALED THAT THE PATIENT WAS IN METABOLIC ACIDOSIS WITH A SODIUM (NA) LEVEL OF 172 AND A PH OF 7.1. THE DT STATED THAT THE PATIENT REMAINED HOSPITALIZED AS OF (B)(6) 2018. ADDITIONAL PATIENT, INTERVENTION, EVENT, AND HOSPITALIZATION DETAILS WERE REQUESTED, BUT WERE NOT PROVIDED. NO SAMPLE WAS AVAILABLE FOR MANUFACTURER ANALYSIS.

  Patient problems: Electrolyte Imbalance; Loss of consciousness

  MAUDE report 8189256 ↗
• InjuryApr 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A DRUM OF NATURALYTE WAS DELIVERED DAMAGED. IT WAS REPORTED THAT THE PRODUCT WAS CRYSTALLIZED ON TOP OF THE DRUM. THE DRUM DID NOT APPEAR TO BE DAMAGED DURING THE SHIPPING PROCESS, HOWEVER, THE CRYSTALLIZED PRODUCT WAS VISIBLE ON THE DRUM WHEN IT WAS DELIVERED. THE FACILITY ALLEGED THAT IT IS RELATED TO THE MANUFACTURING OF THE DRUM. WHILE THE WORKER WAS MOVING THE DRUM, THE CRYSTALLIZED PRODUCT RUBBED OFF ONTO THE WORKERS SAFETY GLOVES. THE PRODUCT FROM THE SAFETY GLOVES CAME IN CONTACT WITH THE WORKER'S BACK AND SUBSEQUENTLY CAUSED BURNS. IT WAS REPORTED THAT THE WORKER NEEDED TO RECEIVE MEDICAL TREATMENT (TREATMENT DETAILS UNKNOWN) FOR THE BURNS. THE WORKER WAS REPORTED TO BE DOING FINE. ADDITIONAL DETAILS REGARDING THE WORKER AND THE REPORTED EVENT WERE REQUESTED, HOWEVER, NOT PROVIDED. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Burn(s)

  MAUDE report 7394031 ↗