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

Model Number 106531INT

Device Problems Disconnection (1171); Material Deformation (2976)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

It was reported that the patient had been experiencing power cable disconnect alarms caused by connectivity issues with their battery clips since (b)(6) 2022 that resulted in a battery clip exchange.After the initial exchange, the issue stopped; however, the patient reported at their outpatient clinic visit on (b)(6) 2022 that the issue had reoccurred a week prior.Upon interrogation, it was noted that the system controller power cables, namely the white power cable, looked worn.The power cable disconnect alarms could not be recreated by manipulation of the battery clips.The system controller was exchanged.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of power cable disconnect alarms which could be related to the power cables was not able to be confirmed.The returned system controller, serial number (b)(6), was functionally tested and was found to function as intended.A full functional test was performed and the system controller passed all test steps.The system controller operated for extended period of time while connected to a mock circulatory loop with no adverse events or alarms noted.The data log files were successfully retrieved.The event log file contained data recorded on (b)(6) 2022, from 11:24 to 12:59 where normal operation was recorded.The system maintained the set speed and there were no atypical alarms recorded.The periodic log file contained events recorded from (b)(6) 2021 to (b)(6) 2022 where normal operation was recorded.The device history records were reviewed and the records revealed the controller was manufactured in accordance with manufacturing and quality assurance (qa) specifications.Heartmate 3 patient handbook (rev g) and heartmate 3 instructions for use (rev.G), under section ¿alarms and troubleshooting¿ explains all alarms and the proper actions to take if the alarms cannot be resolved.The patient handbook also 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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER
• Type of Device: 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14252892
• MDR Text Key: 290458554
• Report Number: 2916596-2022-10699
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/09/2023
• Device Model Number: 106531INT
• Device Lot Number: 7745004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2020
• 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