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Catalog Number 14202 |
Device Problems
Chemical Problem (2893); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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A customer reported the sterrad sealsure chemical indicator tape did not change color correctly after a completed sterrad 100s cycle, and the load was released for use on patients prior to reprocessing.There is 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 when the load is released for use prior to reprocessing.
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Manufacturer Narrative
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The investigation included a review of the device history record (dhr), trending analysis by lot number, concomitant product evaluation and system risk analysis (sra).Per the supplier, no anomalies were observed that would contribute to the customer's experienced issue.Trending analysis by lot number was reviewed from (b)(6) 2017 to (b)(6) 2018 and trending was not exceeded.The concomitant sterrad 100s was evaluated by an asp field service engineer and no problem could be found with the unit.The sra indicates the risk associated with a quality problem with no impact on safety is "low." the product was not returned; therefore, no visual analysis was performed.The assignable cause of the issue can be attributed to user error.The customer likely misinterpreted the color change as the customer stated upon follow-up they did not have any issues with the product changing to the appropriate color.The issue was resolved at the customer site.The issue will continue to be tracked and trended.
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Manufacturer Narrative
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It was originally reported the load was released for use on patients without reprocessing.Upon follow-up with the customer, it was confirmed that the load was not released prior to reprocessing.Therefore, this file is no longer reportable.There is no risk for injury or infection since the load was not released for use.
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Search Alerts/Recalls
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