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

Model Number	103696
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that when the white cable was touched at the connector base, an intermittent sound was activated.A power cable disconnect alarm was noted.The event was reproducible.The patient was to visit the hospital on (b)(6) 2023 to change the system controller.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
Additional information was received that the issue resolved after controller exchange.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of an atypical power cable disconnect alarm was confirmed via the log file that was extracted from the controller during testing.The log file contained data spanning approximately 13 days, and the pump operated at intended speeds while connected to the driveline.A few atypical power cable disconnect and/or low voltage advisory alarms were observed at the beginning of the data.The alarms appeared to have been caused by the voltage within either power cable fluctuating above and/or below the alarm thresholds.The alarms resolved when the patient exchanged power sources, and no other notable events were observed.The returned system controller (serial number (b)(6)) was functionally tested and was found to perform as intended.Atypical events and alarms were unable to be reproduced throughout all testing, even when the controller¿s power cables were manipulated by hand.Every individual wire within the controller¿s power cables was also measured.No atypical measurements were observed, and manipulation of the power cables did not affect the wire measurements.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for the system controller, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The heartmate ii lvas patient handbook (rev.D, table 9 ¿display module alarm messages¿) instructs users on how to resolve alarms that sound from the epc when the display module is connected, including alarms associated with power cable disconnect and low voltage advisory conditions.The heartmate ii lvas patient handbook (rev.D, section titled ¿list of emergency contacts¿) instructs users to call their hospital contact at any time in the event that they think or feel their pump is not operating as intended.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP
• Common Device Name: VENTRICULAR (ASSIST) 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18438388
• Report Number: 2916596-2023-08830
• Device Sequence Number: 20748377
• Product Code: DSQ
• UDI-Device Identifier: 00813024010630
• UDI-Public: (01)00813024010630(17)210319
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2024

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: 03/19/2021
• Device Model Number: 103696
• Device Catalogue Number: 103696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 05/08/2024; 06/20/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 06/03/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 63 KG