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

Model Number 106531US

Device Problem Communication or Transmission Problem (2896)

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

Event Date 06/21/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the system controller not communicating with the system monitor was confirmed via functional testing.The heartmate 3 system controller (serial number: (b)(4)) was returned for analysis and a log file was downloaded for review and showed events spanning approximately 14 days ((b)(6) per timestamp).Events occurring on (b)(6) were recorded during testing at abbott.The log file did not contain any events that would indicate an issue with the system controller.Upon connecting the system controller to the system monitor, the reported event was reproduced.The controller was unable to communicate with the system monitor and a not receiving data message was displayed on the monitor.The power cables of the controller were tested for continuity issues and it was observed that the orange wire in the white power cable was likely compromised, due to its measurement resulting in an open loop.All other underlying wires fell within their accepted resistance thresholds.The cables had their outer jackets removed to further inspect the underlying wires within them.Upon removal of the jacket and protective shield, the orange wire was found to be damaged within the white power cable.The orange wire in the white power cable is responsible for communication between the system monitor and system controller.The power cables were replaced, and the controller was submitted for further testing.With the test cables inserted the controller passed all testing without issue.The controller had no issue communicating with the monitor and was able to support pump function without issue.The root cause for the communication issue was found to be due to damage to the orange wire within the white power cable; however, the root cause for the damage to the wire was unable to be conclusively determined through this analysis.The device history records were reviewed and the records revealed the heartmate 3 system controller (serial number: (b)(4)) was manufactured in accordance with manufacturing and qa specifications.Heartmate iii instructions for use section 7: ¿alarms and troubleshooting¿ and heartmate iii patient handbook section 5 ¿ ¿alarms and troubleshooting¿ explains how to properly interpret and troubleshoot all alarms and also contain a subsection ¿what not to do: driveline and cables¿.This section informs the user to check the system controller power cables for twisting, kinking, or bending which could cause damage to the wires inside.This section informs the user not to ¿twist, kink, or sharply bend the system controller power cables¿ and states, ¿if the driveline or cables become twisted, kinked, or bent, carefully unravel and straighten¿.Heartmate iii instructions for use section 8: ¿equipment storage and care¿ and heartmate iii patient handbook section 6: ¿caring for equipment¿ explain how to properly care for the equipment.Heartmate iii patient handbook and heartmate iii instructions for use (ifu) caution 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.

Event Description

It was reported that the ventricular assist device (vad) coordinator was having trouble connecting the patient's controller to the heartmate touch.The "green check" was not illuminating for her to continue with a connection.Three separate patient cables were tried and the power module had been changed out.The modular cable section of the driveline was kinked and twisted.All troubleshooting options regarding the heartmate touch were walked through with no success with connection.Connection with the backup controller and the heartmate touch was then tried which worked fine.The issue was determined to be either with the patient's controller or the modular cable.Both the controller and modular cable were exchanged and the patient tolerated this well.There have been no alarms since.Related manufacturer reference number: (b)(4).

• 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: 15032254
• MDR Text Key: 304132066
• Report Number: 2916596-2022-11925
• 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
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2024
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 8027603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2021
• 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: 32 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White