Manufacturer's investigation conclusion: review of the patient¿s submitted log files confirmed low speed operation and a pump stoppage; however, evaluation of the replaced portion of the driveline from (b)(6) did not find damage that could have contributed to the events seen within the log file.Additionally, superficial damage to the outer jacket was observed during evaluation of the returned portion of driveline.Finally, evaluation of the submitted log files confirmed low flow events; however, a direct cause for the reported events could not be conclusively determined through this evaluation.The submitted log files contained overlapping data from (b)(6) 2020 and from (b)(6) 2020.The log files recorded pump stoppages and/or low speed operation events on (b)(6) 2020.The patient was operating on 14v external batteries and the power module during all abnormal pump operation.Based on previous complaint experience, the type of behavior captured within the submitted log files could be indicative of a potential driveline issue.Electrical continuity testing of the replaced portion of the driveline in its returned condition revealed no discontinuities or shorts, even with manipulation of the driveline segment.The driveline was covered in rescue tape from approximately 2 inches from the controller connector through the remaining portion of the driveline.The layers were carefully removed, and the underlying wires appeared overall unremarkable with no evidence of kinking, twisting, or severe insulation abrasion.Microscopic inspection of the wires revealed no areas of compromised insulation along the length of the driveline segment.The returned portion of the driveline was then suspended in a saline bath for hipot testing to check for current leakage through the wire insulation, and no areas of compromised wire insulation were identified.Evaluation of the returned portion of the patient¿s driveline did not reveal any issues that could have potentially contributed to the reported events captured in the log files.Review of the device history records showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped to the customer on 09dec2011.The heartmate ii lvas ifu is currently available.The section entitled ¿pump performance monitoring¿ under patient care and management covers wear and tear to the driveline.The ifu warns that at least one power cable must be connected to a power source at all times.Section 1 "introduction" of the ifu provides an explanation of all pump parameters, including pump flow.Section 4 provides more information regarding all pump parameters and also describes situations which may result in a low flow hazard alarm.Section 6 "patient care and management" explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling, explains that pump flow is estimated from pump power, and addresses assessing pump flow.Section 6 (under "anticoagulation") outlines the suggested anticoagulation regimen (including inr range) for patients using the heartmate ii lvas.Section 7 ¿alarms and troubleshooting¿ describes all alarm conditions including the low flow hazard as well as the appropriate actions associated with them.Patient handbook is also available.This handbook contains a section on "caring for the driveline." however, all heartmate ii lvad drivelines have the potential for wire/shield breakdown to occur dependent upon length of use and patient handling.The ¿alarms and troubleshooting¿ section outlines all system controller alarms, including driveline fault alarms, as well as how to respond to such events.No further information was provided.The manufacturer is closing the file on this event.
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