MCB 212 DUAL TANK MIX & DELIVERY BICARB SYSTEM
Received Dec 7, 2018 · Event occurred Nov 14, 2018
Report 3019131-2018-00003 · MDR key 8144049
Device
Product problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Cramp(s)
- Cramp(s)
Narrative
Additional Manufacturer Narrative
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
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.