A user facility biomedical technician (biomed) reported that a fresenius hemodialysis (hd) machine removed too much weight during a patient's hd treatment.It was unknown what the machine was set to remove and how much was actually removed.There were no reported diagnostic messages or audible alarms.It was reported the patient was cramping.During recirculation, the machine was set to remove 100 ml and it removed 150 ml.Upon follow-up, the biomed confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The biomed stated that the machine was returned to service after the ultrafiltration (uf) pump was replaced.The biomed could not confirm if the old uf pump was available to be returned to the manufacturer for evaluation.The treatment details were unknown.
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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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