Alarm history and patient data file review found no new alarms recorded in the freedom driver's eeprom.Visual inspection of internal and external components revealed no abnormalities.Freedom driver failed incoming functional testing for low cardiac output values.Because low cardiac output is typically produced by a defective piston cylinder assembly, a known, viable piston cylinder assembly was substituted.Functional testing was repeated and the driver passed all sections.Failure investigation for this complaint confirmed the reported issue via functional testing.The complaint was replicated via functional testing.The root cause of the reported issue is a faulty piston cylinder assembly.Out of specification left atrial pressure readings caused by faulty piston cylinder assemblies on freedom drivers is a known issue being addressed under capa-2022-0005.Failure investigation identified no other test failure, damage or abnormalities that could have contributed to the reported issue.This complaint was initiated based on routine service and thus there is no patient involvement.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.(if new or additional information is received in the future, syncardia will file a follow-up mdr.) (b)(4) follow-up report 1.
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