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

Model Number	106762
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that the patient could not see the green arrows on their controller anymore.The controller was exchanged.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a dim pump running led was confirmed via visual analysis.The heartmate ii system controller was returned for analysis and a log file was downloaded for review.A review of the submitted log files showed 240 events spanning approximately 48 days ((b)(6) 2021 per timestamp).There were no notable events active in the log file that would indicate an issue with the system controller.The driveline was disconnected on (b)(6) 2021 at 23:51:31 for a system controller exchange.The system controller was connected to a mock loop and was able to support the system for an extended period of time without issue.The power cables of the system controller were manipulated by hand, while connected to the system, without any alarms activating.Upon connection of the power cables to the power module, the dim pump running led was observed, and the reported event was confirmed.The dim led did not affect pump operation.A root cause for the reported event was unable to be conclusively determined through this analysis.Incidental findings: damaged connector nut.The device history records were reviewed and the records revealed the heartmate ii system controller was manufactured in accordance with manufacturing and quality assurance specifications.Heartmate ii instructions for use section 8 ¿ ¿equipment storage and care¿ and heartmate ii patient handbook section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment.Additionally, heartmate ii patient handbook section 10 entitled ¿safety checklists¿, instructs users to regularly inspect their accessories for damage, and to replace any equipment that appears damaged or worn.Heartmate ii instructions for use section 3 ¿ ¿powering the system¿ and heartmate ii patient handbook section 3 ¿ ¿powering the system¿ addresses the user to not use expired batteries and advises the user to properly dispose of them.Heartmate ii patient handbook and heartmate ii instructions for use (ifu) caution 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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11995833
• Report Number: 2916596-2021-02967
• Device Sequence Number: 922271
• Product Code: DSQ
• UDI-Device Identifier: 00813024013013
• UDI-Public: 00813024013013
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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: Health Professional
• Device Expiration Date: 12/06/2019
• Device Model Number: 106762
• Device Catalogue Number: 10005080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 62