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

Model Number 106531US

Device Problems Material Deformation (2976); Data Problem (3196)

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

Event Date 03/18/2022

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 log files from the primary controller were unable to be retrieved.The patient was connected to multiple power modules and system monitors with no success.Significant visible wear and damage was noted on the white power cable and suspected that this might be interfering with the data transfer.Patient death reported under related manufacturer number: 2916596-2022-01869.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the system controller¿s power cables being damaged, resulting in an inability to communicate with the system monitor, was confirmed.The returned system controller (serial number (b)(6)) was observed to have damaged power cables upon arrival, as the cables were slightly kinked, and the inner wires were visible within the white power cable near its bend relief (controller side).The controller was opened and its power cables were replaced with test cables.After this replacement, communication with the monitor was restored.The controller was then functionally tested and was found to perform as intended when test power cables were in use.After communication with the monitor was restored, a log file was extracted from the controller containing data spanning approximately 1 day ((b)(6) 2022 ¿ (b)(6) 2022 per timestamp).A low voltage advisory alarm was observed on (b)(6) 2022 at 5:46 due to extended use of the batteries.This alarm transitioned into a hazard alarm at 5:48, then into a no external power alarm at 5:55 once both batteries had fully depleted.The pump operated on backup battery power until approximately 7:32 of the same day; at this time, the pump was observed to stop, indicating that the backup battery had been fully depleted.The pump¿s speed remained at 0 rpm throughout the remainder of the data ¿ the observed pump stop caused by full battery depletion will be addressed via the pump¿s investigation.No other notable events were observed.The system controller¿s original power cables were opened, and a fractured orange wire within the white cable was observed underneath the damaged bend relief (controller side).This wire is responsible for allowing the controller to communicate with the system monitor.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for system controller, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The heartmate 3 patient handbook, section 10 ¿safety checklists¿ instructs users to regularly inspect their equipment, including their system controllers, and to avoid using equipment that appears damaged.Users are encouraged to replace any equipment that appears damaged.The heartmate 3 patient handbook section titled "emergency contact list" 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 (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: 13999189
• MDR Text Key: 289613896
• Report Number: 2916596-2022-01870
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/05/2022
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7379742
• 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: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2019
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White