A customer reported an event of an ¿odor¿ or smell emitting from the sterrad® 100nx sterilizer.Two female healthcare workers (hcws) experienced human reactions.One hcw felt sensitivity and experienced a headache, and the second hcw experienced shortness of breath and dizziness.Both hcws were ¿checked out¿ in occupational health and reported ¿ok¿ and ¿back to work.¿ advanced sterilization products has requested additional clinical follow-up related to this event, but has received nothing further to date.The customer was instructed to power the unit off and discontinue use.An asp field service engineer was dispatched to assess the unit onsite.Based on the information received to date, the information suggests the neurological and respiratory reactions were not serious.However, this event is being reported as a malfunction report subsequent to a serious injury.
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H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the odor/smells issue, and system risk analysis (sra).¿the device history record (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 odor/smells issue for the sterrad® 100nx unit was reviewed for the prior six months from open date and no significant trend was observed.¿review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low." the oil return solenoid valve was not returned for further evaluation.The assignable cause of the odor/smell is likely due to the oil return solenoid valve.The asp field service engineer replaced the part and confirmed the sterrad® 100nx was restored to proper function after service.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.Asp complaint ref #: cmp-(b)(4).
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