Patient (b)(6) is a study subject in the (b)(6) study with 451 days of support as of (b)(6) 2017.The damaged section of the 70 cc tah-t cannula was not returned by the customer to syncardia, and therefore it could not be evaluated.Syncardia conducted a review of the tah-t device history record (dhr) and sterilization work order and confirmed that all manufacturing was performed to specifications, and the 70 cc tah-t met all specified requirements prior to shipment.Syncardia has initiated a capa (corrective/preventive action) to address the cannula tear issue.The capa will document the investigation including, but not limited to, potential root cause and corrective actions associated with all cannula tear events.The syncardia freedom driver system guidebook for patients and caregivers - us, instructs the patients and caregivers to inspect the drivelines and cannulae daily.If a hole is observed in the drivelines or cannulae, household tape must be applied to temporarily repair the hole and the hospital contact person must be contacted to arrange for a hospital-based evaluation.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) initial.
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The customer, a syncardia certified hospital, reported a cannula tear on the right side requiring repair.The cannula was repaired by cutting off the section of the cannula with the tear and reinserting the cpc connector.There was no reported adverse patient impact as a result of the cannula tear and subsequent repair.
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