A registered nurse (rn), called into technical support requesting field evaluation on the device after a patient "went into cardiac arrest" during his hemodialysis treatment.His blood was returned, cpr was performed and the patient was transported to the emergency room.Follow up w/the rn indicated this patient was being dialyzed on the (b)(6) at his nursing home.He was admitted there as a result of a cerebral bleed due to a motor vehicle accident.She stated he was under more or less "end of life" care.Prior to his treatment on the date of event, her assessment did not show anything unusual.His treatment time was ordered to be three hours.Approximately 1.5 hours into treatment, he became unresponsive w/no breathing or heartbeat.Up to this point, there were no unusual events or indications of impending cardiac issues.There were no unusual device alarms or product malfunctions nor were any alleged.He expired on (b)(6) 2015.
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Medical records were received and the results of the clinical investigation reveal the following: on (b)(6) 2015, approx 1.5 hrs into a 3 hr hd treatment, the pt became unresponsive, went into cardiopulmonary arrest, cardiopulmonary resuscitation was administered, the pt was re-infused with all of his blood returned to him, and was transported to an emergency department and admitted to a hospital.On (b)(6) 2015, the pt expired.The received medical record does not contain dialysis treatment records, progress notes, physician orders, or medication records from the event or outcome dates.Lab data from (b)(6) 2015 showed bicarbonate 32 result.The received medical records did not contain a death certificate or an autopsy report.There is no documentation in the medical record supporting a possible association between the saline solutions, hemodialysis machine, extracorporeal circuit, dialyzer, acid bath, bicarbonate bag, and the event of cardiopulmonary arrest.The machine was evaluated by a field service tech following an adverse pt event.The machine passed the functional checks.The customer has not reported to multiple f/u attempts to determine if the machine has been returned to service.The system level review of the 2008k device and concomitant products found no indication that the products caused or contributed to the clinical event.
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