Model Number 50004 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Appropriate term/code not available- load not recalled.Asp complaint ref #: (b)(4).
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Event Description
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A customer reported a cycle cancellation of an a.10.3 overflow or system leak with their evotech¿ ecr and the cancelled cycle 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, advanced sterilization products (asp) has determined in this situation high level disinfection cannot be assured.Therefore, asp has decided to report all incidents of loads that are released from cancelled cycles prior to reprocessing.
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Manufacturer Narrative
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H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the load not recalled issue, 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.Trending analysis of the load not recalled issue for the evotech¿ ecr unit was reviewed for the prior six months from open date and no significant trend was observed.The sra shows the risk for exposure to biohazardous, pathogenic or infectious material to be "low." the issue has been attributed to user error as the load from the cancelled cycle was released for use on patients prior to reprocessing.A customer letter was sent instructing the customer to review the user¿s guide which states that loads from cancelled cycles should be reprocessed.Asp will continue to track and trend this issue.Asp complaint ref #: (b)(4).
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Search Alerts/Recalls
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