A biomedical technician at the user facility reported that a 2008t hemodialysis (hd) machine had and acid and bicarb pump no eos message.No patient was connected to the machine at the time of the incident.Therefore, no patient was involved.The biomedical technician performed a visual examination and found the drivers were burned and charred.No smoke, flames or sparks were observed.The biomed indicated that hospital grade gfci circuits were used at the facility.The current repair status of the machine is unknown and it is not known if the unit has been returned to service at the user facility.
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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 found the drivers were burned and charred (actuator board).Attempts to gather additional event related information have been unsuccessful.Therefore, the current repair status of the machine is unknown and it is not known if the unit has been returned to service at the user facility.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 results of the in-progress and final quality control (qc) testing met all requirements.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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