[642]
The patient had been on the dialysis machine for approximately two hours, when she called for help stating she needed oxygen. Prior to this call, the run had been uneventful. Air was noted in the venous tubing from the dialysis machine to the patient. The tubing was immediately clamped and resusciatation measures were initiated. The venous port of the quinton catheter was aspirated, however no air was aspirated, only blood. Resuscitation efforts proved unsuccessful. Nursing personnel did not her an audible alarm at the time the patient called for help. After all dialysis line had been clamped, the machine did audibly alarm. Because air was noted in the venous lines, the possibility of an air embolus as cause of death was raised. The dialysis machine is equipped with an air detector alarm and a venous pressure alarm. Either or both alarms should have been activated by the air that was noted in the tubing. Because no alarm was heard, it was believed that the dialysis machine had malfunctioneddevice not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-aug-92. Service provided by: other. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed, mechanical tests performed, performance tests performed, visual examination. Results of evaluation: expected wear/deterioration, mechanical problem, modification of device. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5