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

Model Number 106531INT

Device Problems Mechanical Problem (1384); Material Deformation (2976)

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

Event Date 03/17/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that one of the patient's pins on their system controller's white cable had broken off into their battery clip.The system controller and battery clip were exchanged.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of one of the pins in the white power cable connector of the system controller (serial number: (b)(6) breaking off into the battery clip (lot number: 8116514) was confirmed.Visual inspection of the returned system controller revealed that pin 4, which corresponds to a redundant negative power line, was missing from the white power cable connector.Inspection of the returned battery clip revealed that the missing pin from the controller was stuck in the battery clip connector.The system controller successfully operated in a mock circulatory loop for an extended period of time without any issues or atypical alarms produced.The pin stuck in the battery clip was removed and the system controller was also tested with the returned battery clip with no issues observed.The missing pin did not affect the functionality of the system controller as it corresponds to a redundant signal.The log file downloaded from the returned controller contained approximately 3 days of data ((b)(6) 2022 per the timestamp).No atypical alarms were active in the log file.The driveline was disconnected on (b)(6) 2022 to exchange the system controller.The pump maintained a speed above the low speed limit while the driveline was connected.The root cause of the reported event could not be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The system controller, serial number (b)(6), was shipped to the customer on 25jun2021.Heartmate 3 patient handbook (rev.D), under section 5 ¿alarms and troubleshooting¿ and heartmate 3 instructions for use (ifu) (rev.C), under section 7 ¿alarms and troubleshooting¿ provide guideline for properly connecting and disconnecting the power cable connectors.Heartmate 3 patient handbook (rev.D) section 6 "caring for the equipment" and heartmate 3 ifu (rev.C) section 8 "equipment storage and care" describe how to care for and clean all equipment.Heartmate 3 patient handbook (rev.D) section 10 and heartmate 3 ifu (rev.C) section f, both entitled ¿safety checklists¿, provide checklists to assist the patient in performing routine maintenance of heartmate 3 lvad.This section also informs the user to replace any equipment or system component that appears damaged or worn.Heartmate 3 patient handbook (rev.D) section 2 ¿how your heart pump works¿ and heartmate 3 ifu (rev.C), under section 2 ¿system operations¿ explain the system controller user interface, including the display screen and all buttons, lights, and symbols.Heartmate 3 patient handbook (rev.D) 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.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: 14021500
• MDR Text Key: 288686301
• Report Number: 2916596-2022-01841
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/10/2024
• Device Model Number: 106531INT
• Device Lot Number: 7969910
• 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: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2021
• 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 Weight: 83 KG