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

Model Number	106762
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a controller fault was confirmed via log file analysis.The heartmate ii system controller (serial #: (b)(4)) was not returned for analysis; however, log files were submitted for review spanning approximately 3 days ((b)(6) 2018, (b)(6) 2020 ¿ (b)(6) 2020 per timestamp).From (b)(6) 2020 at 21:20:25 ¿ 21:41:41, there were intermittent time base controller faults.These events did not trigger yellow wrench advisory alarms and would clear on their own.There were no other notable alarms in the log file.Additional information communicated on 18feb2021 indicated that the heartmate ii system controller (serial #: (b)(4)) would not be returning for analysis.The root cause of the reported event was unable to be conclusively determined in this analysis.Heartmate ii instructions for use section 7 entitled ¿alarms and troubleshooting¿ and heartmate ii patient handbook section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms, including controller fault alarms.Heartmate ii instructions for use section 8 entitled ¿equipment storage and care¿ and heartmate ii patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for, maintain, and store the equipment for proper use.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 and the records revealed the heartmate ii system controller (serial#: (b)(4)) was manufactured in accordance with manufacturing and qa specifications.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that on (b)(6) 2020 the patient had multiple icd defibrillation shocks due to multiple arrhythmias (combination of ventricular tachycardia and ventricular fibrillation).The patient became unconscious and emergency services provided cpr and external defibrillation to stabilize heart rhythm.The patient was transferred to the local emergency room where a controller fault alarm occurred.The controller was exchanged to the backup and no other active alarms occurred.The patient was connected to an ungrounded power module patient cable after multiple pump stops occurred due to short-to-shield damage of the driveline cable.The primary controller log file confirmed a pump stop at 14:46 with no further record.The backup controller log file showed multiple pump stops due to short-to-shield events.After connecting to the ungrounded patient cable there were no further issues.Ramp test confirmed adequate left ventricle unloading with lvad inflow cannula in sub-optimal position.The patient was extubated and there were no adverse consequences due to the event.The vad team decided to adjust speed and fluid balance to enlarge lvedd and limit potential contact of inflow with left ventricle wall.An electrophysiology investigation was planned.Due to previously confirmed short-to-shield event, new x-rays and driveline x-rays were performed which confirmed external driveline damage and did not exclude internal damage.Due to another pump stop event, the patient underwent a pump exchange on (b)(6) 2021.Further review of the log file for the backup controller revealed controller faults along with lower than expected 14v bus/rsoc voltages while the backup controller was connected to the power module.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER, EU
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11392132
• Report Number: 2916596-2021-00911
• Device Sequence Number: 3384052
• Product Code: DSQ
• UDI-Device Identifier: 00813024013013
• UDI-Public: 00813024013013
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/15/2021
• Device Model Number: 106762
• Device Catalogue Number: 10005080
• Device Lot Number: 6545778
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1