Asp investigation summary: the investigation included a review of the device history record (dhr), service history, trending of the product malfunction code, and system hazard user misuse analysis (shuma).Service history, trending and shuma reviewed.The dhr was not reviewed as the lot number of the cassette was not available.The service history for the past six months (12/06/2013 to 06/04/2014) did not identify any significant trend.The trend for the product malfunction code of skin reaction was assessed from july 2013 through june 2014.The risk is considered "as low as reasonably practicable".The shuma indicates the risk is "broadly acceptable." the instructions for use (ifu) of the sterrad® 100nx state: "warning! hydrogen peroxide may be present.Wear chemical resistant latex, pvc (vinyl), or nitrile gloves whenever handling a load after a cycle cancellation or when disposing of a cassette.Hydrogen peroxide liquid may be present on the cassette, the load or in the chamber." testing was not performed as there was no product returned.The assignable cause is attributed to user error.The customer was educated on proper handling of used cassettes.Review of tracking and trending data did not reveal a trend.As a result, root cause was not performed.
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