MCB Series BICARD SYSTEM, MCB212-100, LG 220V/50HZRecalls & reported problems
Mar Cor Purification, Inc. · MCB SERIES · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817492021785), received between Dec 7, 2018 and Dec 7, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Cramp(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 7, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE FACILITY REPORTED THE INCORRECT CONCENTRATION OF BICARBONATE SOLUTION FROM THE MCB 212 BICARB SYSTEM WAS DELIVERED FROM THE DISTRIBUTION TANK TO THE LOOP AND TO PATIENTS. THE CONCENTRATION OF BICARBONATE SOLUTION WAS DILUTED DUE TO AN OPERATOR LEAVING A VALVE OPEN WHILE CLEANING THE MIX TANK DURING PATIENT TREATMENTS. TWELVE (12) PATIENTS WERE RECEIVING DIALYSIS TREATMENT AT THE TIME. THE FACILITY REPORTED PATIENTS WERE EXPERIENCING CRAMPING.
Patient problems: Cramp(s)
MAUDE report 8144049 ↗
Other Tank, Holding, Dialysis devices
- Sodium Bicarbonate Mixing and Distribution System IsoMix PROIsopure, Corp. · Tank, Holding, Dialysis2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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