A customer reported a positive result with a cyclesure® 24 biological indicator (bi) after a completed sterrad® 100s cycle.The bi was incubated for 24 hours.The chemical indicator (ci) changed color correctly.The affected load was released and used on a patient.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 positive cyclesure® 24 biological indicators when the load has been released and used on patient(s) prior to reprocessing.
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Additional information regarding the bi: bi integrity (glass ampoule intact, cap not depressed, ci disc unchanged, purple media color, etc.) was checked prior to use recommended asp product instructions were followed asp incubator was used for incubation the documented incubation temperature at time of incubation was 55°c-60°c the load was dry prior to sterrad® processing the bi was processed in single tyvek® pouch the pcd/test pack integrity was verified prior to use (hole is clear, clean, etc.) the bi was placed at back of the chamber the tape or a label was not placed over cyclesure¿s cap holes prior to sterrad® processing the cap was depressed after the sterrad® processing.The bi was crushed properly using the supplied tube crusher the bi was crushed after sterrad® processing.There was no reduction in media and/or leakage observed immediately after sterrad® processing.The vial was punctured during the crushing process (maybe puncture in plastic vial, media leak or protruding glass).There was no media ampoule broken when the bi was activated.There was no vial broken when the bi was activated the liquid in the bi was shaken into the growth reservoir after the bi was activated.H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, system risk analysis (sra), visual analysis and retains analysis.¿ trending analysis by lot number was reviewed for the previous six months from open date and trending was not exceeded.¿ the sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." ¿ a photograph of the complaint device provided by the customer was used in lieu of product return analysis.One (1) bi the cap is depressed and the media in the vial was observed being purple in color.One (1) bi the cap is depressed and the media in the vial was observed being yellow in color.The suspect positive issue is confirmed.¿ thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.It is unlikely that the complaint issue was caused by a manufacturing issue in the cyclesure product since the dhr review found no anomalies that would contribute to complaint issue, retains met specifications and lot history review did not exceed trending.User error was identified during follow-up.The vial was punctured during the crushing process.Therefore, the assignable cause can be attributed to user error.A customer letter will be sent to address the released load and user error.The issue will continue to be tracked and trended.Asp complaint ref #: cmp-(b)(4).
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