A user facility reported that the "dialysate hose ruptured" on a 2008t hemodialysis (hd) machine while a patient was undergoing a routinely scheduled hd treatment.Reportedly, the patient inadvertently moved the machine while dialyzing, and by doing so, caused the dialysate tubing to "snap off," which led to dialysate "going everywhere." the patient was disconnected from the system, and then re-setup on another machine to complete the hd treatment.The blood within the extracorporeal circuit was not returned to the patient.The patient's estimated blood loss (ebl) was noted as being approximately 250ml.No patient adverse effects were experienced and no medical intervention was required as a result of this event.Following the event, the 2008t hd machine was removed from service for evaluation.The dialysate hose was removed and was found to be visibly damaged.The biomedical technician replaced the dialysate hose on the 2008t hd machine to resolve the issue.The unit has been returned to service at the user facility without a recurrence of the event as reported.No parts are available to be returned to the manufacturer for evaluation.
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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.The biomedical technician provided follow-up information which revealed that the 2008t hd machine was removed from service for evaluation following the event.The dialysate hose was removed and was found to be visibly damaged.The biomed replaced the dialysate hose to resolve the issue.The unit has been returned to service at the user facility without a recurrence of the event as reported.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 deviations or non-conformances during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the material and process controls were within specification.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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