Plant investigation: the reported complaint is not confirmed as the complaint device was not available for manufacturer evaluation, and the serial number of the suspect device was not provided.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.An investigation of the device manufacturing records was not able to be conducted by the manufacturer as the serial number of the hemodialysis (hd) machine in question was not known.However, all device history records (dhr) are reviewed and released according to the "dhr review checklist & release procedure." p/n 500658; a device is not released if it does not meet requirements or is nonconforming.
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