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 and user misuse analysis (shuma).¿the dhr was not reviewed as the assignable cause was user error.¿the service history trending was not performed as lot number of the involved cassette is not available.¿the trend for the product malfunction code of skin reaction was assessed from january 2014 through december 2014.The risk is considered "low." ¿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 of the reported issue is user error as no ppe was used when handling a used cassette.A customer letter was sent advising a review of the proper handling of used cassettes.The severity of this issue is defined as "limited." review of the tracking and trending data did not identify a trend that needed further investigation.The issue will be tracked and trended.
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