Catalog Number 10104 |
Device Problem
Device Disinfection Or Sterilization Issue (2909)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/23/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Brand name - the correct brand name is sterrad 100nx sterilizer.Common device - the correct common device is sterrad equipment.Catalog number - the correct catalog number is 10104-003.Serial number - the correct serial number is (b)(4).
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Event Description
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A customer reported encountering an issue of suspect positive biological indicator after a completed sterrad®100nx express cycle.It was additionally reported that the customer self-identified user error as one of the employees had processed the scopes on the top shelf versus the bottom shelf on an express cycle.The affected scopes were reprocessed and there was no report of injury or harm to patient(s) associated with this issue.Although there is no report of any serious 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 loads processed on the top shelf of the sterrad®100nx sterilizer during an express cycle.
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Manufacturer Narrative
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Asp investigation summary: the investigation included a review of the device history record (dhr) and system risk analysis (sra).The dhr was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release.The sra shows the risk of a quality problem with no impact on safety to be "low." no parts were replaced to resolve the issue.The assignable cause of the procedure related issue is due to user error.The customer was processing a scope on the top shelf of the sterrad 100nx in the express cycle for which the scope was not approved for.The customer self-identified the processing issue.Therefore, no further training/education was needed.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.
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Search Alerts/Recalls
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