A user facility reported that a fresenius 2008t hemodialysis (hd) machine did not start ultrafiltration as programmed during a patient¿s hd treatment.Upon follow up, the clinic¿s biomedical technician (bmt) stated that he swapped out the machine¿s function board with another machine, and ran several self tests.The bmt could not duplicate the issue, nor find any defect or damage on the machine or its parts.It was confirmed that the machine is in service without further issue, and that the ultrafiltration issue was most likely operator error.It was confirmed that there was no patient injury, adverse event, or medical intervention required as a result of the reported event.It was confirmed that the patient completed treatment as prescribed and that their pre- and post-treatment weights were as expected.Additional patient and event information was requested, but was not available.
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).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 identified 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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