The user facility medical records which were provided for an unrelated event stated that a patient, with history of severe cardiomyopathy, experienced a sudden unresponsive event while undergoing a hemodialysis treatment on (b)(6) 2014.Treatment was initiated at 10:23 am.Approximately 15 minutes later, the patient suddenly became unresponsive.The patient's breathing was noted as being irregular so respiratory resuscitation via ambu bag was performed and the patient regained consciousness.The patient was transported to the hospital and admitted with a pre-syncope and bradycardia diagnosis.On (b)(6) 2014, while hospitalized, the patient underwent a follow-up hemodialysis treatment and experienced a secondary event of bradycardia, hypotension and unresponsiveness.Cardiopulmonary resuscitation (cpr) was performed and the patient was intubated.The patient recovered, but was no longer considered a candidate for hemodialysis due to severe cardiomyopathy and ejection fraction 10%.A peritoneal dialysis (pd) catheter was placed and the patient began pd on (b)(6) 2014.However, the patient has since returned to having hemodialysis treatments.The patient's current condition was noted as "doing well." no product information was made available.There are no allegations of device malfunctions having occurred.No complaint device is available for evaluation by the manufacturer.
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Manufacturing investigation: the device was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A manufacturing review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius bloodlines shipped to this account within the selected time frame.A records review was performed on all lots identified.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lots passed all release criteria.A review of the batch production records did not reveal a probable cause for the customer complaint.There were no non-conformances identified that relate to the reported event, and all lots met release criteria.Therefore, the adverse event experienced by the patient cannot be confirmed as it relates to the fresenius bloodline.Clinical investigation: the patient medical records were provided by the facility on march 11, 2016.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.While undergoing a hemodialysis (hd) treatment on (b)(6), 2014, a patient, with a history of severe cardiomyopathy, experienced a sudden unresponsive event.The patient was transferred, and then admitted to the hospital.The patient underwent a follow-up hd treatment in the hospital on (b)(6), 2014 and subsequently experienced a second event of bradycardia, hypotension, and unresponsiveness.At that time, the patient was found to no longer qualify to receive hd treatments.A peritoneal dialysis catheter was placed and the patient began peritoneal dialysis on (b)(6), 2014.However, the patient has since returned to having hemodialysis treatments.The patient¿s current condition was noted as ¿doing well.¿ there is no documentation in the medical record that indicates a causal relationship between the 2008k hemodialysis machine and the patient¿s pulseless electrical activity (pea) arrest.There is no documentation in the medical record that indicates a causal relationship between the optiflux 160nre dialyzer and the patient¿s pea.There is no documentation in the medical record that indicates a causal relationship between the fresenius bloodline and the patient¿s pea.The cause of the patient¿s pea arrest during the hemodialysis treatment was thought to be due to patient¿s inability to handle hemodialysis.The patient was switched to peritoneal dialysis without any further issues.
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