The cpc (colder products company) connector is a component that provides the interface between the drivelines and the tah-t cannula.The customer, a syncardia certified hospital, reported that the right cpc connector on the freedom driver was missing the spring.The customer also reported that the patient was subsequently switched to a backup freedom driver.There was no reported adverse patient impact.
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The customer-reported issue of a missing spring was confirmed during the visual inspection of the driver's external components, where there was no spring in the female cpc connector.Despite the spring missing from the cpc connector housing, the drivelines were able to be connected to a tah-t during investigation testing, and the driver passed all test sections.Although a definitive root cause for the spring coming out of the cpc connector housing could not be determined, it is possible that a cpc connector spring can be displaced during the insertion of a wire tie, or pulled out of the connector housing when the wire tie is removed from the connector during or after a driver switch.As reported by the customer, the missing spring could have been caused by the way the zip (wire) ties were being placed, which would align with the determined failure mode.Syncardia has an open corrective and preventive action (capa) to address this issue with cpc connectors.Syncardia has completed its evaluation and is closing this file.Ce 4218 follow-up report 1.
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