CER-2 OPTIMA

Additional Manufacturer Narrative

THE FACILITY REPORTEDLY OBSERVED THAT THE METRICIDE OPA PLUS HIGH LEVEL DISINFECTANT USED IN THEIR CER-2 OPTIMA AUTOMATED ENDOSCOPE REPROCESSOR HLD RESERVOIR WAS CLOUDY IN APPEARANCE. THE FACILITY CONFIRMED THAT THE OPA SOLUTION WAS NOT EXPIRED AND THE MINIMUM REQUIRED CONCENTRATION (MRC) PASSED FOR THE REPROCESSING CYCLE. THE INITIAL REPORTER THOUGHT SOMEONE MAY HAVE ACCIDENTALLY TOPPED OFF THE DISINFECTANT RESERVOIR WITH METRIZYME DETERGENT, WHICH THEY USE AS PART OF THEIR PRE-CLEANING STEP PRIOR TO HIGH-LEVEL DISINFECTING SCOPES. THEREFORE, IT IS UNKNOWN IF SCOPES WERE PROPERLY HIGH-LEVEL DISINFECTED. IT IS ALSO UNKNOWN IF SCOPES WERE USED ON PATIENTS, THUS POTENTIAL RISK OF PATIENT ADVERSE EFFECTS FROM IMPROPER HLD OF SCOPES. MEDIVATORS TECHNICAL SERVICES ADVISED THE CUSTOMER TO DUMP THE DISINFECTANT FROM THE RESERVOIR, RINSE THOROUGHLY WITH WATER, THEN REFILL WITH THE OPA SOLUTION AND TEST THE MRC USING THE SOLUTION TEST STRIPS. THE CUSTOMER FOLLOWED THESE DIRECTIONS AND CONFIRMED THAT THE MRC PASSED. TO DATE, THERE HAVE BEEN NO REPORTS OF PATIENT HARM. MEDIVATORS WILL CONTINUE MONITORING THIS COMPLAINT IN THE MEDIVATORS COMPLAINT HANDLING SYSTEM.

Description of Event or Problem

A FACILITY REPORTED NOTICING THE METRICIDE OPA PLUS HIGH LEVEL DISINFECTANT USED IN THEIR CER 2 OPTIMA AUTOMATED ENDOSCOPE REPROCESSOR HLD RESERVOIR WAS CLOUDY IN APPEARANCE. IT WAS SUSPECTED THAT SOMEONE ACCIDENTALLY TOPPED OFF THE DISINFECTANT RESERVOIR WITH METRIZYME DETERGENT. THERE IS POTENTIAL FOR PATIENT ADVERSE EFFECTS SUCH AS CROSS CONTAMINATION IF SCOPES ARE NOT PROPERLY HIGH LEVEL DISINFECTED.