Manufacturer's investigation conclusion the heartmate 3 system controller (serial number: (b)(4) is being evaluated for communication faults.The controller was not returned for analysis; however, a log file was submitted for review.A review of the submitted log files showed events spanning approximately 11 days (24feb2022 ¿ 07mar2022 per timestamp).Lvad internal faults coincident with eeprom communication faults were active throughout the entire log file.There were no other notable alarms in the log file.Pump operation was not affected.An additional log file was submitted following the controller exchange.A review of the submitted log files showed events spanning approximately 4 days (b)(6) 2020, (b)(6) 2000, (b)(6) 2020, and (b)(6) 2022 per timestamp).Events captured on (b)(6) 2000 took place when the clock was not set; therefore, the exact date and times were unable to be accurately recorded.The driveline was connected on (b)(6) 2022 at 00:01:11 and the clock was set to (b)(6) 2022 at 14:16:40.There were no other notable alarms active in the log file.Pump operation was not affected.The heartmate 3 patient handbook states that driveline communication faults and communication fault alarm conditions do not display on the controller.The root cause of the reported event was conclusively determined to be unrelated to the system controller.Heartmate iii instructions for use, rev.C, section 7 entitled ¿alarms and troubleshooting¿ and heartmate iii patient handbook, rev.C, section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms including lvad fault alarm conditions, and the actions to take if the alarms cannot be resolved.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.The device history records were reviewed for the system controller (serial number: (b)(4) and was found to pass all manufacturing and qa specifications before being shipped to the customer on (b)(6) r2021.No further information was provided.The manufacturer is closing the file on this event.
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Related manufacturer report number:2916596-2022-01836.Related manufacturer report number:2916596-2022-01597.It was reported that the patient was transferred to the intensive care unit (icu).They presented with shortness of breath (sob), pneumonia, and pulmonary edema.There was a twisted driveline.The heartmate 3 system controller and heartmate 3 modular cable were exchanged after which the pump speed returned to 5800 rpm.A review of the log files revealed the date this event first occurred couldn't be determined because both log files are filled with lvad fault events.The oldest date in the event & periodic log files was (b)(6) 2022 so this event occurred on an unknown date prior to (b)(6) 2022.The lvad faults were the result of a communication error.This resulted in the actual pump speed defaulting to the default speed of 5000 rpm.Additional information revealed the patient was intubated for previous concern for pneumonia.Now the increased lvad output will hopefully alleviate the pulmonary edema.The photo of the driveline shows the twisted driveline.This is caused by the patient repeatedly rotating the controller 360 degrees.
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