A customer reported an event of cidex® opa solution being used at 17.2 degrees celsius to reprocess a transesophageal echocardiogram (teec) probe, and the probe was released and used on a patient.As per the cidex® opa instructions for use (ifu), the minimum temperature for reprocessing is 20 degrees celsius.There was no report of any injuries or human reactions.As a matter of policy since high level disinfection cannot be assured, advanced sterilization products (asp) has decided to report all incidents of cidex® opa solution being used under the minimum reprocessing temperature and the instrument was released and used on a patient.
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The customer confirmed understanding of the instructions for use and declined product training for the staff who were involved with the reported issue.Asp investigation summary: batch review was not performed as the lot number for the cidex® opa solution was not available.Trending was not performed as the lot number for the cidex® opa solution was not available.Review of risk documentation shows the risk for exposure to biohazardous, pathogenic, or infectious material to be "low." supplier investigation and product evaluation was not performed as the lot number is not available, and the reported issue was determined to be user error.The most likely assignable cause is failure to follow the instructions for use, which requires cidex® opa solution to be at a minimum of 20 degrees celsius for manual processing, and utilization of a thermometer was recommended to ensure optimum conditions are met.Asp will continue to track and trend this issue.Asp complaint ref #: (b)(4).
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