Centrisol Liquid Bicarbonate Concentrate MB-330-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00677964000409), received between Jul 26, 2016 and Aug 3, 2017 — classified as 2 deaths, 2 injuries.

The most frequently reported specific device problem is “Improper Chemical Reaction” (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 18, 2026.

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.

• DeathAug 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USER FACILITY REPORTED THAT DURING A HEMODIALYSIS TREATMENT, THE PATIENT GASPED, AND THEN CODED. AFTER CANCELLING THE TREATMENT AND REMOVING THE PATIENT FROM THE MACHINE, THE CODE CONTINUED FOR ONE HOUR AND THIRTY MINUTES, AFTER WHICH TIME, THE PATIENT EXPIRED. IT WAS REPORTED THAT THE ADVERSE EVENT WAS CAUSED BY A PULMONARY EMBOLISM (PE). MEDIVATORS LIQUID BICARBONATE WAS USED IN THE DIALYSATE SOLUTION FOR DIALYSIS TREATMENT.

  Patient problems: Death; Patient Problem/Medical Problem

  MAUDE report 6765625 ↗
• InjuryFeb 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FACILITY REPORTED PATIENT DEVELOPED RIGORS, FEVER AND WAS DIAGNOSED WITH PNEUMONIA AFTER PATIENT DIALYSIS TREATMENT.

  Patient problems: Fever; Pneumonia

  MAUDE report 6333205 ↗
• InjuryJan 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT BECAME UNRESPONSIVE DURING RECEIPT OF HEMODIALYSIS TREATMENT. CENTRISOL LIQUID BICARBONATE WAS USED IN THE DIALYSATE SOLUTION FOR DIALYSIS TREATMENT OF THIS PATIENT.

  Patient problems: Cardiac Arrest; Renal Disease, End Stage

  MAUDE report 6231076 ↗
• Aug 8, 2016Improper Chemical Reaction; Improper Chemical Reaction

  THE CASE STATES PATIENTS EXPERIENCED NAUSEA AND VOMITING AFTER RECEIVING HEMODIALYSIS TREATMENT. MEDIVATORS LIQUID SODIUM BICARBONATE WAS A COMPONENT USED IN THEIR DIALYSATE SOLUTION.

  Patient problems: Nausea; Vomiting

  MAUDE report 5853244 ↗
• DeathJul 26, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) PATIENT EXPIRED WHILE RECEIVING DIALYSIS TREATMENT. MEDIVATORS CENTRISOL LIQUID BICARBONATE CONCENTRATE WAS USED IN THE DIALYSATE SOLUTION FOR DIALYSIS TREATMENT ON THIS PATIENT.

  Patient problems: Death

  MAUDE report 5822643 ↗