Citrasate 08-2251-CARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840861101344), received between Dec 22, 2020 and Dec 22, 2020 — classified as 1 malfunction.

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

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 16, 2026.

Recalls naming this device

1. Jul 14, 2026Open, Classified

   Complaints of blue-green discoloration in product

   Z-3093-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

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 22, 2020Chemical Problem; Chemical Problem

  IT WAS REPORTED A BIOMEDICAL TECHNICIAN (BMT) RECEIVED LOW CONDUCTIVITY VALUES ON A HEMODIALYSIS (HD) MACHINE WITH A LOT OF CITRASATE ACID. UPON FOLLOW UP, THE BMT CLARIFIED THAT THE EVENT OCCURRED WHILE TESTING THE CITRASATE PRIOR TO PATIENT TREATMENT. THE MACHINE ALARMED LOW CONDUCTIVITY AND DISPLAYED A CONDUCTIVITY VALUE OF 13.1 MS/CM. THE THEORETICAL CONDUCTIVITY VALUE WAS SET TO 13.5 MS/CM. SHE CONFIRMED THAT THIS TEST WAS THE FIRST TIME THE REPORTED LOT HAD BEEN USED. THE REMAINING JUGS OF THIS LOT WERE SEQUESTERED AND WERE NOT USED. THE BIOMED IS UNSURE WHICH PART OR LOT NUMBER OF ACID WAS USED SUCCESSFULLY AFTER THE REPORTED INCIDENT. THE CLINIC USES BIBAGS BI-CARBS (UNKNOWN PART AND LOT NUMBER). THERE ARE FOUR CASES OF THE REPORTED LOT REMAINING AT THE CLINIC. THE BMT INDICATED SAMPLES ARE AVAILABLE TO RETURN. A PICKUP WAS SCHEDULED TO RETURN A SAMPLE.

  Patient problems: No Patient Involvement

  MAUDE report 11058518 ↗