CER 1 OPTIMA

Additional Manufacturer Narrative

MEDIVATORS CLINICAL EDUCATION SPECIALIST (CES) WAS ONSITE AT A FACILITY AND OBSERVED A HOOKUP CHANNEL WAS OCCLUDED, AND NOT ALLOWING HIGH LEVEL DISINFECTANT SOLUTION TO FLOW THROUGH THE ENDOSCOPE. THUS, THE ENDOSCOPE WAS NOT ADEQUATELY HIGH LEVEL DISINFECTED. THE HOOKUP IS AN ACCESSORY TO THE CER 1 OPTIMA AUTOMATED ENDOSCOPE REPROCESSOR (AER). MEDIVATORS CES CONFIRMED THE OCCLUDED HOOKUP WAS (B)(4). THIS HOOKUP WHEN USED PER INSTRUCTION FOR USE DELIVERS HIGH LEVEL DISINFECTION SOLUTION TO THE AUXILIARY WATER JET CHANNEL FOR AN ENDOSCOPE. THE FACILITY REPORTED TO MEDIVATORS CES THEY WERE NOT PERFORMING THE DAILY QA TEST PER THE CER 1 OPTIMA USER MANUAL WHICH ENSURES ALL BASIN PORT CHANNELS ARE PROVIDING HIGH LEVEL DISINFECTION SOLUTION TO THE ENDOSCOPE VIA A HOOKUP. MEDIVATORS CES CLEARED THE BLOCKAGE FROM THE HOOKUP AND TESTED IT IN THE AER. THE HOOKUP MEETS ALL REQUIREMENTS AND IS PERFORMING AS INTENDED. IT IS UNKNOWN HOW LONG THE HOOKUP CHANNEL WAS OCCLUDED. THE FACILITIES AER UNIT WAS FIRST INSTALLED IN 2006 AND THE FACILITY HAS NOT HELD A SERVICE CONTRACT WITH MEDIVATORS SINCE 2007. BASED ON THE DETAILS PROVIDED THE OCCLUDED HOOKUP IS NOT CAUSED BY A MALFUNCTION OF THE DEVICE BUT USER ERROR BECAUSE THE FACILITY DID NOT PERFORM THE REQUIRED DAILY QA TESTS FOR THE AER AS INDICATED IN THE CER 1 OPTIMA USER MANUAL. 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 OBSERVED A HOOKUP CHANNEL WAS OCCLUDED, AND NOT ALLOWING HIGH LEVEL DISINFECTANT SOLUTION TO FLOW THROUGH THE ENDOSCOPE. THUS, THE ENDOSCOPE WAS NOT ADEQUATELY HIGH LEVEL DISINFECTED. THE HOOKUP IS AN ACCESSORY TO THE CER 1 OPTIMA AUTOMATED ENDOSCOPE REPROCESSOR (AER).