Citrasate 13-3251-CARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840861101382), received between Dec 2, 2020 and Dec 2, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Chemical Problem” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY EXPERIENCED LOW CONDUCTIVITY DURING TREATMENT WITH A BATCH OF CITRASATE. UPON FOLLOW UP WITH THE BMT IT WAS REPORTED HE WAS ASKED TO SERVICE THE MACHINE FOR THE LOW CONDUCTIVITY. HE DOES NOT RECALL THE EXACT CONDUCTIVITY VALUES, BUT THE ACTUAL VALUE WAS 0.4 MS/CM BELOW THE THEORETICAL CONDUCTIVITY VALUE. THE MACHINE NEVER REACHED THE THRESHOLD LIMITS TO TRIGGER A BYPASS. THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT WITH THIS BATCH. THERE WAS NO ADVERSE EVENT NOR MEDICAL INTERVENTION ATTRIBUTED TO THIS EVENT. ALL OF THE BATCHES WERE DISCARDED. THE CLINIC WAS USING NATURALYTE DRY BICARB (UNKNOWN LOT).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10931989 ↗