CER-1R

Additional Manufacturer Narrative

IT WAS REPORTED THAT A FACILITY WAS REPROCESSING ENDOSCOPES WITH THEIR CER-1 AUTOMATIC ENDOSCOPE REPROCESSOR (AER) WITH THE INCORRECT AMOUNT OF RINSES PER THE HIGH-LEVEL DISINFECTANT LABELING AND AER INSTRUCTIONS-FOR-USE. THE FACILITY WAS USING CIDEX OPA HLD WHICH REQUIRES 3 RINSES BUT THEIR AER WAS SET UP WITH 2 RINSES. THERE IS POTENTIAL THAT ENDOSCOPES MAY HAVE CONTAINED HLD RESIDUAL AFTER REPROCESSING WHICH COULD CAUSE CHEMICAL COLITIS OR ADVERSE REACTIONS TO PATIENTS. MEDIVATORS DISCOVERED THAT THE FACILITY ORIGINALLY HAD THEIR AER SETUP FOR USING RAPICIDE HLD WHICH REQUIRES 2 RINSES. THE FACILITY SWITCHED TO USING CIDEX OPA AND DID NOT HAVE THE FIRMWARE CHIP REPLACED IN THEIR AER TO INCORPORATE THE 3RD RINSE PER THE HLD AND AER INSTRUCTIONS. MEDIVATORS INFORMED THE CUSTOMER OF THE REQUIRED 3 RINSES FOR USE WITH CIDEX OPA AND SWITCHED THE FIRMWARE CHIP IN THEIR UNIT TO HAVE THE CORRECT AMOUNT OF RINSES. CIDEX OPA LABELING AND INSTRUCTIONS AND MEDIVATORS CER-1 USER MANUAL CLEARLY STATE 3 RINSES ARE REQUIRED WHEN USING CIDEX OPA TO REPROCESS ENDOSCOPES. IT IS UNKNOWN HOW LONG THE FACILITY HAD BEEN USING CIDEX OPA WITH THE INCORRECT AMOUNT OF RINSES. THERE HAVE BEEN NO REPORTS OF PATIENT HARM. THIS COMPLAINT WILL CONTINUE BEING MONITORED IN MEDIVATORS COMPLAINT HANDLING SYSTEM.

Description of Event or Problem

IT WAS REPORTED THAT A FACILITY WAS REPROCESSING ENDOSCOPES WITH THEIR CER-1 AUTOMATIC ENDOSCOPE REPROCESSOR (AER) WITH THE INCORRECT AMOUNT OF RINSES PER THE HIGH-LEVEL DISINFECTANT LABELING AND AER INSTRUCTIONS-FOR-USE. THE FACILITY WAS USING CIDEX OPA HLD WHICH REQUIRES 3 RINSES BUT THEIR AER WAS SET UP WITH 2 RINSES. THERE IS POTENTIAL THAT ENDOSCOPES MAY HAVE CONTAINED HLD RESIDUAL AFTER REPROCESSING WHICH COULD CAUSE CHEMICAL COLITIS OR ADVERSE REACTIONS TO PATIENTS.