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

Model Number 106531US

Device Problems Low Audible Alarm (1016); Failure of Device to Self-Test (2937)

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

Event Date 10/20/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient was experiencing changes to the auditory self-test on their system controller.The alarms appeared to be quieter and change or disappear throughout the time of one self-test.This began to happen more frequently, and appeared to be occurring with every self-test the patient had performed in the last week.The patient's controller was exchanged.

Manufacturer Narrative

Manufacturer's investigation conclusion: device history records were reviewed and showed no deviations from manufacturing or qa specifications.The system controller, serial number (b)(6), was shipped to the customer on 17jan2019.The heartmate 3 patient handbook instructs 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.The 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.The reported event of the sound changing during a self test was not confirmed as the system controller was not returned for evaluation.The provided log file was reviewed; however, it contained no information related to the reported event.It was reported that the system controller was exchanged; however, it will not be returned for analysis.As result, the root cause of the reported event could not be conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER
• 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: 12851325
• MDR Text Key: 281094675
• Report Number: 2916596-2021-06524
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/08/2021
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 6751592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2018
• 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
• Patient Sex: Male
• Patient Weight: 92 KG