MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER; VENTRICULAR (ASSISST) BYPASS

Model Number	106531INT
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
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 when the patient initiates a controller self test, the sound flickers.The controller will be exchanged.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the sound flickering during a self test was not confirmed as the system controller was not returned for evaluation.It was reported that the system controller was exchanged but was kept as a backup controller.The root cause of the reported event could not be conclusively determined through this analysis.Heartmate 3 patient handbook section 6 entitled ¿caring for the equipment¿ and heartmate 3 instructions for use section 8 entitled ¿equipment storage and care¿ address how to properly care for, maintain, and store the equipment for proper use.These sections instruct users to check the system controller¿s audio speakers at least once per month.If a change in sound is noted during a self-test, the speakers may be obstructed.Audio speaker sockets may be cleaned using a small cotton swab that is moistened (not dripping) with rubbing alcohol.Never insert anything sharp (like a toothpick or pin) into the sounder holes.This can damage the speakers inside.Heartmate 3 patient handbook section 2 "system operations" and heartmate 3 instructions for use section 2 "how your heart pump works" explain how to perform a self test, and describe the characteristics of a self test.The documents state that the system controller should be replaced if it fails a self test.Heartmate 3 patient handbook section 10 ¿safety checklists¿ and heartmate 3 instructions for use section f "safety checklists" provides checklists to assist the patient in performing routine maintenance of heartmate 3 lvad, including the system controller.Heartmate 3 patient handbook cautions 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.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.The system controller, (b)(6) , was shipped to the customer on 22oct2017.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11247640
• Report Number: 2916596-2021-00094
• Device Sequence Number: 3563140
• Product Code: DSQ
• UDI-Device Identifier: 00813024013013
• UDI-Public: 00813024013013
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

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: 05/31/2020
• Device Model Number: 106531INT
• Device Catalogue Number: 10005080
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1