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

Model Number 106531

Device Problem Failure to Power Up (1476)

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

Event Date 05/31/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient came into the clinic with a 'power cable disconnect' message and a yellow light illuminated on the patient's white lead.They stated that they attempted to change their system controller at home and the backup controller didn't start as intended so they switched back to their primary controller.

Manufacturer Narrative

Manufacturer's investigation conclusion: the heartmate 3 system controller (s/n: (b)(6)) was evaluated following the reported event of the pump not starting as intended.A review of the log files contained overlapping data spanning approximately 1 hour (31may22, 10:29:57 - 11:37:16 per timestamp).From 10:29:57 ¿ 10:34:24, several lift_off and rot_displ fault flags were captured, without any apparent flow through the pump (mean flow values were captured at 0.0 liters per minute for these events).Elevations in pump current (lvad monitor iimc) were captured during these events, over 400 ma (maximum of 1240 ma).The maglev monitor mode alternated between rollon, bearon, and pwroff.The pump began to operate as intended at 10:34:24 and regained speed above the lsl at 10:34:25.The controller operated as intended throughout the log files.The system controller was not returned for analysis.Provided information stated no product will be returned.The delayed pump start could not be correlated to an issue with the system controller.Heartmate 3 instructions for use, rev.C, section 7 - ¿alarms and troubleshooting¿ and heartmate 3 patient handbook, rev.D, section 5 - ¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot all alarms.Heartmate 3 patient handbook, rev.D, section 2 - ¿how your heart pump works¿ and heartmate 3 instructions for use, rev.C, section 2 - ¿system operations¿ explain how to replace the running system controller with a backup controller.The user is instructed to not attempt to change the system controller without having a trained, competent caregiver by their side to assist.The patient handbook 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.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Related manufacturer report number: 2916596-2022-13285.

• 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: 14753895
• MDR Text Key: 300232639
• Report Number: 2916596-2022-11457
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 813024013235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/29/2024
• Device Model Number: 106531
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2021
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White