The clinic manager reported that the bloodlines had clotted during a patient treatment due to no movement of the blood although the blood pump was actively spinning at 400ml/min.The machine did not alarm.The clinic manager stated that the pressure parameters are reset and had expected the machine to alarm when this happened but there were no machine alarms.The clinic manager stated that the air in the arterial bloodline would be pulled off to show that the blood is moving, but the blood in the bloodlines after the blood pump does not move and clots within the circuit.There are no allegations of malfunction or defect with the dialyzer (unknown manufacturer) or bloodlines (medisystems).The patient did not experience any adverse reaction or injury.No medical intervention was required.The patient experienced blood loss (estimated volume is unknown) as the blood in the external circuit was clotted and was not returned to the patient.The patient completed treatment with a new set-up of supplies on the machine.The clinic manager stated that this occurred with five patients since (b)(6) 2017.The machine serial number, actual date of event, and patient information is unknown.One submission will be filed for each of the reported five patients from (b)(6) 2017 through the report date (reported in (b)(6) 2017).This submission documents the event on an unknown date, selected as (b)(6) 2017.The clinic manager stated that some of the machines¿ blood pump modules have been replaced by the facility biomedical technician.All machines are currently in service at this time.There are no parts available to be returned to the manufacturer for evaluation.
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Plant 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).Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.An investigation of the device manufacturing records was not able to be conducted by the manufacturer as the serial number of the 2008t hemodialysis (hd) machine in question was not known.However, all device history records (dhr) are reviewed and released according to the "dhr review checklist & release procedure." p/n 500658; a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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