NaturaLyte 08-1001-0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840861101627), received between Oct 16, 2020 and Oct 16, 2020 — classified as 3 injuries.

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEMODIALYSIS (HD) USER FACILITY REPORTED TO FRESENIUS CUSTOMER SERVICE (CS) THAT THEY HAD PREVIOUSLY RECEIVED THE WRONG ORDER OF NATURALYTE PRODUCT. ADDITIONALLY, IT WAS REPORTED THAT A PATIENT ON HEMODIALYSIS (HD) THERAPY WAS HOSPITALIZED AS A RESULT. THERE WERE NO REPORTED ALLEGATIONS THAT THE NATURALYTE DELIVERED WAS DEFECTIVE. ADDITIONAL INFORMATION WAS OBTAINED VIA FOLLOW-UP WITH THE CLINIC'S FACILITY ADMINISTRATOR (FA). THE FA CONFIRMED THE CLINIC RECEIVED NATURALYTE 1001 1K 0.0CA 1MG JUGS INSTEAD OF NATURALYTE 1001 1K 2.5CA 1MG JUGS. THE FA STATED THE CLINIC USED WHAT WAS DELIVERED ON UNKNOWN DATE(S) FOR THE PATIENT, AND THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED FOR HYPOCALCEMIA. ADDITIONAL DETAILS SURROUNDING THE PATIENT¿S HOSPITALIZATION (SUCH AS CALCIUM LEVELS, TREATMENT AND DISCHARGE DATES) AND PATIENT INFORMATION (NAME, DATE OF BIRTH, AND AGE) ARE UNKNOWN DESPITE MULTIPLE DUE DILIGENCE ATTEMPTS. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10694482 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEMODIALYSIS (HD) USER FACILITY REPORTED TO FRESENIUS CUSTOMER SERVICE (CS) THAT THEY HAD PREVIOUSLY RECEIVED THE WRONG ORDER OF NATURALYTE PRODUCT. ADDITIONALLY, IT WAS REPORTED THAT A PATIENT ON HEMODIALYSIS (HD) THERAPY WAS HOSPITALIZED AS A RESULT. THERE WERE NO REPORTED ALLEGATIONS THAT THE NATURALYTE DELIVERED WAS DEFECTIVE. ADDITIONAL INFORMATION WAS OBTAINED VIA FOLLOW-UP WITH THE CLINIC'S FACILITY ADMINISTRATOR (FA). THE FA CONFIRMED THE CLINIC RECEIVED NATURALYTE 1001 1K 0.0CA 1MG JUGS INSTEAD OF NATURALYTE 1001 1K 2.5CA 1MG JUGS. THE FA STATED THE CLINIC USED WHAT WAS DELIVERED ON UNKNOWN DATE(S) FOR THE PATIENT, AND THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED FOR HYPOCALCEMIA. ADDITIONAL DETAILS SURROUNDING THE PATIENT¿S HOSPITALIZATION (SUCH AS CALCIUM LEVELS, TREATMENT AND DISCHARGE DATES) AND PATIENT INFORMATION (NAME, DATE OF BIRTH, AND AGE) ARE UNKNOWN DESPITE MULTIPLE DUE DILIGENCE ATTEMPTS. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10694481 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEMODIALYSIS (HD) USER FACILITY REPORTED TO FRESENIUS CUSTOMER SERVICE (CS) THAT THEY HAD PREVIOUSLY RECEIVED THE WRONG ORDER OF NATURALYTE PRODUCT. ADDITIONALLY, IT WAS REPORTED THAT A PATIENT ON HEMODIALYSIS (HD) THERAPY WAS HOSPITALIZED AS A RESULT. THERE WERE NO REPORTED ALLEGATIONS THAT THE NATURALYTE DELIVERED WAS DEFECTIVE. ADDITIONAL INFORMATION WAS OBTAINED VIA FOLLOW-UP WITH THE CLINIC'S FACILITY ADMINISTRATOR (FA). THE FA CONFIRMED THE CLINIC RECEIVED NATURALYTE 1001 1K 0.0CA 1MG JUGS INSTEAD OF NATURALYTE 1001 1K 2.5CA 1MG JUGS. THE FA STATED THE CLINIC USED WHAT WAS DELIVERED ON UNKNOWN DATE(S) FOR THE PATIENT, AND THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED FOR HYPOCALCEMIA. ADDITIONAL DETAILS SURROUNDING THE PATIENT¿S HOSPITALIZATION (SUCH AS CALCIUM LEVELS, TREATMENT AND DISCHARGE DATES) AND PATIENT INFORMATION (NAME, DATE OF BIRTH, AND AGE) ARE UNKNOWN DESPITE MULTIPLE DUE DILIGENCE ATTEMPTS. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10694480 ↗