A customer reported the sterrad® sealsure chemical indicator tape did not change color correctly after a completed sterrad® 100s cycle.The affected load was reprocessed.There was no report of infection, injury or harm to patient(s) associated with this issue.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.
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Asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, concomitant product evaluation, system risk analysis (sra), visual analysis and retains analysis.¿ the dhr, trending analysis of lot number, visual analysis and retains analysis were not reviewed since the lot number was not available.¿ the concomitant sterrad® 100s was tested by an asp field service engineer (fse).The fse replaced a part and confirmed the unit met specifications.It is inconclusive whether the part replacement is related to this issue.¿ the sra indicates the risk associated with a quality problem with no impact on safety is "low." there is insufficient information to determine an assignable cause.The lot number was not available and the complaint product was not provided by the customer.Dhr review, lot trending, and retains product testing could not be performed.Should additional information be received, the complaint will be re-opened and re-evaluated.The issue will continue to be tracked and trended.
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