MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II SYSTEM CONTROLLER, US, EP; VENTRICULAR (ASSISST) BYPASS

Model Number 103696

Device Problems No Audible Alarm (1019); Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, the company was informed that on (b)(6) 2022 the patient went into asystole and the pump was not audible upon auscultation.According to history review, the power source for the pump was changed from wall power to batteries to restart the pump which ran for about 6 hours before driveline was disconnected.The driveline was then reinserted and pump resumed operation, afterwards the fixed speed decreased.About two hours later the pump stopped again and the pump stop button was pressed on the system monitor and the driveline disconnected shortly after and the pump never restarted.The driveline was disconnected to facilitate controller exchange and the pump stop button had been intentionally pressed.The suspected downtime was 20 minutes upon paramedics arrival.There was no audible alarm or light from the controller.Even after the controller was exchanged, there was no effect the pump did not restart.The patient was intubated and given inotropes in another hospital pending transfer to hospital laval (the patient lived remotely 1 hour 40 minutes away from hospital laval).Electrical rhythm returned at one point and the patient was sent to be transferred, but then the patient became unstable and needed to be cardioverted.The treatment was unsuccessful, the patient passed away on (b)(6) 2022.An autopsy was performed and the pump will be returned.Related manufacturer report number # 2916596-2022-00834.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of no audible alarms from the system controller when connected to a power source was not confirmed.The heartmate ii system controller (serial #: (b)(6)) was evaluated after it was reported that the patient had expired.The heartmate ii system controller (serial #:(b)(6)) was returned for analysis, and the system controller was determined to be the patient¿s backup controller.The downloaded log file spanned approximately 8+ hours, according to time stamps.The pump was set at a fixed speed of 8800 rpm and then to 9400 rpm and at a low speed limit (lsl) of 8200 rpm.At the timestamp of day 0 hour 06 minute 06, the log file captured pump stops/pump disconnected events.A low speed advisory/hazard, a low flow hazard, and a low speed operation/motor stopped flags actively accompanied these events and were associated with red heart alarms.The timestamp of day 0 hour 06 minute 07 revealed that the pump was reconnected to the system controller where the pump was operated at the set speed (8800 rpm) for approximately 23 minutes, and then the pump speed was adjusted to 9400 rpm.After the pump speed adjustment, the system continued to operate for approximately 1 hour and 55 minutes.During this period, the log file recorded multiple intermittent low flow hazard alarms associated with flow estimation below 2.5 lpm.At the timestamp of day 0, 08 hours, and 02 minutes, power to the controller was interrupted, which was indicated by the time clock reset to 0 days, 0 hours, and 0 minutes.During this time, various alarm conditions were recorded, including low speed hazard alarm, a low flow hazard alarm, and a motor stopped command received flag.Since the power was restored, the log file recorded several power interruption events, possibly due to unsuccessfully attempting to start the pump.The returned controller was operated with pump disconnected active flags throughout the end of the log file.The system controller (b)(6) was tested and passed all preliminary and functional testing stages.The device was able to operate on a mock loop with no issues.The reported event could not be correlated to the returned (b)(6) controller.Device history records were reviewed.The device was manufactured in accordance to mfg and qa specifications.Heartmate ii system controller (b)(6) was shipped to the customer on (b)(6) 2020.The heartmate ii lvas patient handbook cautions users that a loss of power to the system controller will make the pump stop running.Power must be restored right away to restart the pump.The heartmate ii lvas patient handbook provides instruction on how to handle an emergency and what to do if the pump stops running.The heartmate ii lvas patient handbook instructs patients to keep a list of emergency contacts at all times.Patients are urged to call the hospital if they think that the pump is not working correctly.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

The serial number was changed from (b)(6) to (b)(6) because based on the log files epc-(b)(6) was determined to be the primary controller in use when the controller did not have audible alarm during pump stop.Investigation of the returned controller (b)(6) revealed it was the backup controller and was in use at the time of patient death.There were no allegations against (b)(6) and it could not be correlated to the reported event.Manufacturer's investigation conclusion: the reported event of no audible alarms from the system controller when connected to a power source was confirmed.The evaluation of the returned heartmate ii system controller serial number (b)(6) found the controller non-functional when connected to a test system in our lab.The controller did not respond nor operate an hm ii test pump in its received condition.The examination of the returned system controller revealed opened/electrically damaged fuses on the controller's main pcb.The damaged fuses prevented the controller from operating the pump and collecting the event data.The electrically damaged components were replaced, and the system controller function was restored.After the repair, the log file was collected; the log file contained 120 relevant events spanning approximately 2 days and 10 hours of data (day 47, hour 07, minute 00 - day 49, hour 17, minute 08, per the timestamps).From timestamp of day 47, hour 07, minute 00 to day 49, hour 08, minute 34, the log file contained multiple low voltage advisory events, which can indicate operation on depleted (discharged) 14-volt li-ion batteries.The system was routinely operated with no notable changes to the pump speed where the motor (pump) speed matched the set speed without interruptions, and the supply voltage remained in the operational range.At the timestamp of day 49, 17 hours and 08 minutes, while a power module supported the controller, the power to the controller was interrupted, which was indicated by the time clock reset to 0 days, 0 hours, and 0 minutes.The log file then captured the driveline being disconnected associated with motor stopped, low speed hazard, and low flow hazard alarm events.Motor stopped, low speed hazard, low flow hazard, and pump disconnected alarms were addressed via the pump investigation.The findings of the damaged drive and power circuitry components are consistent with an overcurrent situation related to a compromised driveline, which was confirmed during the evaluation of the returned pump (mfr#2916596-2022-00834).Device history records were reviewed.The device was manufactured in accordance to mfg and qa specifications.Heartmate ii system controller (b)(6) was shipped to the customer on 13feb2014.The heartmate ii lvas patient handbook cautions users that a loss of power to the system controller will make the pump stop running.Power must be restored right away to restart the pump.The heartmate ii lvas patient handbook (section titled ¿handling emergencies¿) provides instruction on how to handle an emergency and what to do if the pump stops running.The heartmate ii lvas patient handbook (section titled ¿list of emergency contacts¿) instructs patients to keep a list of emergency contacts at all times.Patients are urged to call the hospital if they think that the pump is not working correctly.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER, US, EP
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13515408
• MDR Text Key: 287360145
• Report Number: 2916596-2022-00841
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010630
• UDI-Public: 00813024010630
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/21/2016
• Device Model Number: 103696
• Device Catalogue Number: 103696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1