A biomedical engineer (biomed) at a user facility reported that during a patient¿s hemodialysis (hd) treatment using a fresenius 2008t hd machine, the goal ultrafiltration (uf) had been reached with 56 minutes of treatment left on the machine.The blood flow rate was decreased from 450 to 425 and shortly after, the machine alarmed stating that the uf goal was met.The uf did not changed.No adjustments were made using the up or down arrow keys.The patient¿s treatment was ended at that time (56 minutes early) as the uf goal was met.(b)(6), meeting the patient¿s uf goal of approximately 4000ml.There was no patient injury or adverse reaction.No medical intervention was required.Following the event, the machine was removed from service for further evaluation.The on-site biomed verified machine operations.The biomed could not duplicate any uf problems.The machine was tagged to be returned to service at the user facility; however, it is unknown if the machine has been used since this event.No parts are 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 unit was pulled from service for evaluation by the facility biomedical engineer (biomed) following the event.The biomed verified all machine operations and could not duplicate any ultrafiltration (uf) problems.The machine was tagged to be returned to service at the user facility; however, it is unknown if the machine has been used since this event.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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