Manufacturer investigation: 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.Attempts to gather additional event related information have been unsuccessful.Therefore, the current repair status of the machine is unknown.The unit has remained out of service since (b)(4) 2017 and the biomed has indicated that on-site service by a fresenius res will be performed following approval of the po request by the user facility¿s compliance officer.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 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.Clinical investigation: there is an allegation against the 2008k2 machine stating that the uf control function failed and the documentation in the medical records indicated that there was a possible causal relationship between the 2008k2 machine and the subsequent discrepancy of 1.6kg of weight gain post hd treatment.The patient experienced no adverse events and no medical intervention was required.
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A nurse at a user facility reported that the 2008k2 hemodialysis (hd) machine ultrafiltration (uf) pump was not removing the proper amount of fluid during a patient¿s hd treatment.The patient¿s pre-weight was(b)(6) kilograms (kg), which was noted as being 1.4kg over the estimated dry weight (edw).At the initiation of hd treatment, the patient was reportedly alert and denied complaints.The hd treatment continued as expected with no patient adverse event and no reported machine alarms or malfunction until approximately one and a half hours into treatment when the uf was turned off for an unknown reason.At this time, the uf fluid removed was documented at 950ml, the patient's vitals were stable, and the patient complained of feeling hot, but had no other complaints and no intervention was recorded.An hour later, the hd treatment was discontinued.The total hd treatment time was two (2) hours and thirty (30) minutes for a scheduled hd treatment for three (3) hours forty-five (45) minutes.It was reported that the patient had arrived late for hd treatment and refused to complete treatment.Post hd treatment, the patient was reportedly alert and orientated.The patient¿s post hd treatment weight was 78kg, which was a total of a 1.6kg weight gain.However, the expected weight reduction was 0.65kg from the pre hd treatment weight of 76.4kg.The net uf removed (as recorded on the 2008k2 machine) was 650ml, in which a discrepancy of 1.6kg of weight gain exists.It was reported that the machine¿s uf had been turned off for an hour during hd treatment, but the reason was unknown and that the patient did not eat or drink during hd treatment.It was further reported that the patient was weighed standing by the staff and that the facility¿s scale is calibrated and working without issue.The 2008k2 machine passed all machine setup functions.The patient did not experience any adverse effects and no medical intervention was required.Additionally, the patient¿s spkt/v (measurement of clearance of urea) recorded for the hd treatment was 1.27, with the standard of adequate dialysis is at a minimum kt/v of 1.2.The 2008k2 hd machine was removed from service for evaluation by the biomed.The biomed did not provide specific information on the machine status but indicated that at some point in time during troubleshooting, the diasafe filter and balancing chamber membranes were replaced and the machine was but back into service.Currently, the machine remains out of service pending on-site evaluation by a fresenius regional equipment specialist (res).No further information has been made available.
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