BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCB 212 DUAL TANK MIX & DELIVERY BICARB SYSTEM

    MDR report key: 8144049 · Received December 7, 2018

    Report

    Report Number
    3019131-2018-00003
    Event Type
    Injury
    Date Received
    December 7, 2018
    Date of Event
    November 14, 2018
    Report Date
    December 7, 2018
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIN
    UDI-DI
    00817492021785
    PMA / PMN Number
    K003560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. ACCORDING TO THE FACILITY, THE BICARBONATE SOLUTION IN THE DISTRIBUTION TANK WAS ACCIDENTALLY DILUTED AS AN OPERATOR LEFT A VALVE OPEN WHILE THEY WERE CLEANING THE MIX TANK DURING PATIENT TREATMENTS. RO WATER FROM THE MIX TANK COMBINED WITH THE OUTGOING BICARB SOLUTION FROM THE DISTRIBUTION TANK CAUSING MORE UNUSED FLUID FROM THE LOOP TO BE RETURNED TO THE DISTRIBUTION TANK, THUS FURTHER DILUTING THE BICARB SOLUTION. THIS RESULTED IN THE DIALYSIS MACHINES ALARMING FOR LOW LEVEL. VIDEO FOOTAGE FROM THE FACILITY CONFIRMED THE SOLUTION LEVEL INCREASE IN THE DISTRIBUTION TANK AND THEY OBSERVED ONE OF THE STAFF MEMBERS CLEANING THE MIX TANK AND NOT PROPERLY SHUT OFF THE VALVES. THE MCB 212 BICARB SYSTEM USER MANUAL CLEARLY WARNS USERS NOT TO DISINFECT THE MIX TANK WHILE DIALYZING PATIENTS AS POSSIBLE HARM COULD OCCUR. THE FACILITY REPORTED TO HAVE RETRAINED THEIR STAFF TO PREVENT THIS ISSUE FROM REOCCURRING. MAR COR PURIFICATION REGULATORY FOLLOWED UP WITH THE FACILITY AND THEY REPORTED A NURSE FOLLOWED UP WITH ALL THE PATIENTS RECEIVING DIALYSIS AT THE TIME AND CONFIRMED THEY WERE ALL DOING BETTER. NO ADDITIONAL MEDICAL ATTENTION WAS SOUGHT. THIS COMPLAINT WILL CONTINUE BEING MONITORED IN MAR COR PURIFICATION'S COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984254 MCB 212 DUAL TANK MIX & DELIVERY BICARB SYSTEM BICARB SYSTEM FIN MAR COR PURIFICATION MCB 212 00817492021785

    Patients

    Seq Age Sex Outcome Treatment
    1 Other