Manufacturer's investigation conclusion: the device history records were reviewed for the system controller (serial number: (b)(4)) and was found to pass all manufacturing and qa specifications before being shipped to the customer on 15sep2020.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.Heartmate iii instructions for use entitled ¿equipment storage and care¿ and heartmate iii patient handbook section 6 entitled ¿equipment maintenance¿ addresses how to properly care for, maintain, and store the equipment for proper use.The report that the patient's heartmate 3 (hm3) screen had discoloration was confirmed via the photo submitted to this complaint.The system controller lcd screen was discolored, and green was consistent with fluid ingress into the controller; the green discoloration did not prevent the parameters from being displayed or legible.The system controller (serial #: (b)(4)) was not returned for analysis.Provided information indicated that the controller was not exchanged.The discoloration of the lcd does not appear to be affecting the controller/pump operation.At this time, the tech service recommends monitoring the discoloration.If the discoloration worsens and starts to interfere with the display readings or unusual alarms are seen, the controller should be replaced.To date, the system controller (serial #: (b)(4) will not be returned for analysis.As a result, this complaint file will be closed with no further action.If the product is returned at a later time, the complaint file will be re-opened.No further information was provided.The manufacturer is closing the file on this event.
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