A biomedical engineer (biomed) at a user facility reported that the fresenius 2008k2 hemodialysis (hd) machine had a burned actuator/test board.The machine had been removed from service for semi-annual preventative maintenance (pm).A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The biomed stated that during pm, the acid pump was not pulling acid.While troubleshooting, the actuator/test board was adjusted, and the pump was examined.When the machine was turned back on, a burning smell was noticed, and smoke was visible.There was no flame or spark.The machine was turned off and there was a visible burned spot and melted area on the actuator/test board.This was the original component to the machine.It was reported that when the actuator/test board was reinstalled after the acid pump problem, the biomed did not properly insert it, causing the burn damage.The actuator/test board was replaced to resolve the issue; however, after replacement, the machine was giving ¿failed sending data¿ messages.The function board was replaced, but the board software version did not match the actuator/test board version.The machine is currently out of service pending receipt of an upgraded function board.No parts have been made available to be returned to the manufacturer for evaluation.
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res).The biomedical technician (biomed) replaced the burned actuator/test board to resolve the issue.However, after replacement, the machine was giving ¿failed sending data¿ messages.The function board was replaced, but the board software version did not match the actuator/test board version.The machine is currently out of service pending receipt of an upgraded function board.No further information was made available.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 non-conformances or any associated rework during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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