CLMAC-MV1R

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE FACILITY USED OVEN CLEANER TO CLEAN THEIR CLMAC-MV1R AUTOMATED ENDOSCOPE REPROCESSOR (AER) WHICH DAMAGED THE AER BASIN. THERE IS POTENTIAL FOR ENDOSCOPES TO BE CONTAMINATED IF THEY ARE REPROCESSED INSIDE THE AER THAT WAS SPRAYED WITH OVEN CLEANER; THUS, POTENTIAL FOR PATIENT HARM. MEDIVATORS FIELD SERVICE ENGINEER (FSE) WAS ON SITE AT THE FACILITY FOR A PREVENTATIVE MAINTENANCE SERVICE OF ANOTHER AER. THE FSE WAS INFORMED BY THE FACILITY THAT OVEN CLEANER WAS USED ON THE AER AND CAUSED THE BASIN TO CRACK AND TURN DARK BROWN. WHEN THE FSE OBSERVED ENDOSCOPES BEING REPROCESSED IN THE AER, HE ADVISED THE FACILITY TO DISCONTINUE USING THE AER AND TO NOT USE THOSE ENDOSCOPES IN PATIENT PROCEDURES SINCE THE AER BASIN WAS CONTAMINATED WITH OVEN CLEANER. MEDIVATORS CLMAC-MV1R AER USER MANUAL INSTRUCTS USERS HOW TO PROPERLY CLEAN THE AER BASIN. USING OVEN CLEANER TO CLEAN THE AER BASIN IS NOT IN ACCORDANCE WITH THE USER MANUAL. MEDIVATORS DISTRICT MANAGER INFORMED THE FACILITY DIRECTOR THAT IT WOULD NOT BE SAFE TO USE THE MACHINE FOR FUTURE USE. THE FACILITY PURCHASED A NEW AER AND SENT ALL AFFECTED ENDOSCOPES OFF-SITE TO BE REPROCESSED IN THE MEANTIME. IT IS UNKNOWN IF ENDOSCOPES REPROCESSED IN THE CONTAMINATED AER WERE USED IN PATIENT PROCEDURES. THERE HAVE NOT BEEN ANY REPORTS OF PATIENT OR USER HARM. THIS COMPLAINT WILL CONTINUE BEING MONITORED IN THE MEDIVATORS COMPLAINT HANDLING SYSTEM.

Description of Event or Problem

IT WAS REPORTED THAT THE FACILITY USED OVEN CLEANER TO CLEAN THEIR CLMAC-MV1R AUTOMATED ENDOSCOPE REPROCESSOR (AER) WHICH DAMAGED THE AER BASIN. THERE IS POTENTIAL FOR ENDOSCOPES TO BE CONTAMINATED IF THEY ARE REPROCESSED INSIDE THE AER THAT WAS SPRAYED WITH OVEN CLEANER; THUS, POTENTIAL FOR PATIENT HARM.