CER 1 OPTIMA

Additional Manufacturer Narrative

MEDIVATORS CLINICAL EDUCATION SPECIALIST (CES) WAS ONSITE AT A FACILITY AND FOUND TWO OF FOUR BASIN PORT CHANNELS IN THEIR CER-1 AUTOMATED ENDOSCOPE REPROCESSOR (AER) WERE NOT WORKING. THUS, NO HLD WOULD HAVE BEEN DELIVERED TO A CONNECTED HOOKUP WHICH DELIVERS HLD TO CHANNELS OF THE ENDOSCOPE. THERE IS POTENTIAL RISK FOR CROSS-CONTAMINATION. THE FACILITY TOLD MEDIVATORS CES THEY WERE NOT PERFORMING THE DAILY QA TEST PER THE CER-1 USER MANUAL WHICH CHECKS THE FLOW THROUGH THE BASIN PORT CHANNELS. THE CER-1 AER ONLY HAS FOUR BASIN PORT CHANNELS THAT DELIVER HLD TO THE HOOKUP ATTACHED THAT IS ATTACHED TO AN ENDOSCOPE. THE NUMBER OF BASIN CHANNEL PORTS NEEDED FOR REPROCESSING IS DEPENDENT ON THE ENDOSCOPES THE FACILITY IS REPROCESSING. THIS UNIT WAS FIRST INSTALLED IN 2006 AND THE FACILITY HAS NOT HELD A SERVICE CONTRACT WITH MEDIVATORS SINCE 2007. THE FACILITY IS RESPONSIBLE FOR THE MAINTENANCE OF THEIR AER AND SHOULD HAVE BEEN PERFORMING THE DAILY QA TEST TO ENSURE ALL BASIN PORT CHANNELS WERE DELIVERING HIGH LEVEL DISINFECTION SOLUTION TO ENDOSCOPES. IT IS UNKNOWN HOW LONG THE TWO BASIN PORT CHANNELS WERE NOT WORKING AND HOW MANY ENDOSCOPES THIS COULD HAVE AFFECTED. THE FACILITY REPORTS THEY HAVE APPROXIMATELY FOUR PATIENTS EVERY OTHER WEEK. MEDIVATORS CES INFORMED THE FACILITY THEY SHOULD STOP USING THE AER IMMEDIATELY AND HAVE IT REPAIRED. THE MALFUNCTION OF THE DEVICE IS A RESULT OF USER ERROR AND FAILURE TO FOLLOW THE CER-1 USER MANUAL. THE FACILITY REPORTED THEY HAVE CONTINUED USE OF THE AER BECAUSE THEIR ENDOSCOPES ONLY REQUIRES TWO CONNECTIONS FROM THE BASIN PORT CHANNELS. THEY REPORT THEY ARE NOT USING THE BROKEN BASIN PORTS CHANNELS. THERE HAVE BEEN NO REPORTS OF PATIENT HARM. THIS COMPLAINT WILL BE MONITORED IN THE MEDIVATORS COMPLAINT HANDLING SYSTEM.

Description of Event or Problem

MEDIVATORS CLINICAL EDUCATION SPECIALIST (CES) WAS ONSITE AT A FACILITY AND FOUND TWO OF FOUR BASIN PORT CHANNELS IN THEIR CER-1 AUTOMATED ENDOSCOPE REPROCESSOR (AER) WERE NOT WORKING. THUS, NO HLD WOULD HAVE BEEN DELIVERED TO A CONNECTED HOOKUP WHICH DELIVERS HLD TO CHANNELS OF THE ENDOSCOPE. THERE IS POTENTIAL RISK FOR CROSS-CONTAMINATION.