Clinical review of the medical records do not reveal any documentation of a cause for the patient¿s heart attack.The lack of information, including the patient¿s comorbidities, do not allow for assessment of a causal relationship between peritoneal dialysis with fresenius products and the patient¿s heart attack.A return product investigation was not performed as the cycler was not replaced in the complaint for the reported symptoms.Field service investigation is not performed on cyclers.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device record review confirmed the labeling, material, and process controls were within specification.The system level review of the liberty cycler and concomitant products found no indication of a causal relationship between the products and the patient event.
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