The actuator board of a 2008t hemodialysis (hd) machine was found to be "charred" during a routine service repair.Reportedly, the technician who troubleshot the machine was wearing a metal bracelet which came in contact with the actuator board and resulted in minor charring to the board.No smoke was observed, and no flames or sparks were noted.There was no adverse effects experienced by the technician as a result of this event.No patient involvement as the issue occurred while the machine was being serviced.The unit has been returned to service at the user facility without issue.
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The device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis.The biomedical technician provided follow-up information which revealed that the actuator board of a 2008t hemodialysis (hd) machine was found to be "charred" during a routine service repair.Reportedly, the technician who troubleshot the machine was wearing a metal bracelet which came in contact with the actuator board and resulted in minor charring to the board.The biomed replaced the actuator board and deaeration pump to resolve the issue.Following the parts replacement, the system was restored to full functionality.The unit has been returned to service at the user facility without issue.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the material and process controls were within specification.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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