A user facility clinical manager (cm) reported that a patient expired following hemodialysis (hd) treatment.Seventeen minutes after the initiation of the patient¿s hemodialysis (hd) treatment, it was discovered that the prescribed blood flow rate (bfr) could not be achieved.The machine, a fresenius 2008t machine, did not alarm.Staff reversed the patient¿s bloodlines in an effort to improve the patient¿s bfr, and a hemaclip was applied to the arterial lumen and venous bloodline of the patient¿s hd catheter; the treatment was restarted.At approximately 15:30, the patient was observed having difficulty breathing and was visibly pale, and blood was noted on the patient¿s right finger.The patient¿s catheter ports were clamped and a saline bolus was administered.Although it is unknown if the hemaclip was attached to the catheter or the bloodline, it was confirmed that the hemaclip did not pose any imposition while the saline bolus was administered to the patient.It was noted that the venous bloodline separated from the arterial lumen of the patient¿s permanent hd catheter (not a fresenius product).It was confirmed that emergency medical services (ems) were called and cardiopulmonary resuscitative (cpr) was initiated.The patient expired in the emergency room at approximately 16:16.Additional information regarding the patient and the event was requested; however, not provided by the facility.The hospital declined to provide the patient¿s records to the clinic.Upon follow up, it was confirmed that the clinic did not contact the catheter manufacturer to confirm that the hemaclip was compatible with the patient¿s catheter type.It was also confirmed that the patient¿s catheter dressing was changed and that chloroprep was used at the catheter site.It was reported that the devices involved were discarded and there are no parts available for manufacturer evaluation.
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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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