The customer reported the sterrad sealsure chemical indicator tape did not change color correctly after a completed sterrad 100s cycle.It is unknown if the affected load was recalled or released for use.It is unknown if there was any injury.Although there is no report of patient injury or harm and no prior incidents have resulted in serious injury, advanced sterilization products (asp) has determined in this situation sterility cannot be assured.Therefore, as a matter of policy asp had decided to report all incidents of sterrad sealsure chemical indicator tape not changing color correctly.(b)(4) are related complaints from the same facility.This is two of two 3500a reports being submitted for this product malfunction.Please reference manufacturer report number: 2084725-2015-00469.
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Method: actual device not evaluated.Result: no results available since no evaluation performed.Asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, and system risk analysis (sra).Per the supplier's certificate of conformance all process specifications were met before release of product.Trending analysis by lot number was reviewed from 04/12/2015 to 10/09/2015 and trending was not exceeded.The sra indicates the risk associated with a quality problem with no impact to safety is "low." the product was not returned; therefore, no visual analysis was performed.The cause could not be verified.The customer suggested that sometimes heavier loads are ran at the facility which could be the cause of the issue however this cannot be definitively concluded.It is unlikely that the issue was with the unit as cycle completed and other indicators were changing properly.However, the customer stated all three of their sterrad® 100s units were experiencing the same issue.The customer was unresponsive to asp's attempts to obtain additional information.The issue will continue to be tracked and trended.
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