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

Model Number 106531US

Device Problems Improper or Incorrect Procedure or Method (2017); Communication or Transmission Problem (2896); Material Deformation (2976)

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

Event Date 02/18/2022

Event Type  malfunction  

Event Description

It was reported that the patient's controller was not communicating with the system monitor.The system monitor worked as intended with the backup controller.The controller white lead data cable was suspected of damage.The patient's controller was exchanged and the issue resolved.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of communication issue between the system controller and the system monitor was able to be confirmed.The heartmate 3 system controller (serial number: (b)(6)) was returned for analysis, and a log file was downloaded for review.A review of the submitted log files showed events spanning approximately 5 days (18feb2022, 25feb2022, 18apr2022, 12may2022, 01jan2000 per timestamp).Events captured on 25feb2022 and after took place in the testing labs at abbott.Events captured on 01jan2000 took place when the clock was not set; therefore, the exact dates and times were unable to be accurately recorded.The driveline was disconnected on 18feb2022 at 15:35:33 and the controller was shut off at 15:36:07.There were no other notable alarms active in the log file.Pump operation was not affected.Upon initial testing, the controller did not communicate with the system monitor.The controller underwent circuit analysis and the voltage signal was lost at the output of the integrated circuit (ic) u9.The ic was replaced with a functional ic and the controller was then connected to a system monitor and was found to operate as intended.The system controller underwent preliminary and functional testing following the repair and passed.The system controller was able to operate a mock loop without any alarms active and was able to function as intended.The root cause of the reported event was unable to be conclusively determined through this investigation.The device history records were reviewed for the system controller (serial number: (b)(6)) and was found to pass all manufacturing and quality assurance specifications before being shipped to the customer.Heartmate iii instructions for use (rev.C) section 7 entitled ¿alarms and troubleshooting¿ and heartmate iii patient handbook (rev.C) section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms including power cable disconnect alarms.Heartmate iii instructions for use (rev.C) section 8 entitled ¿equipment storage and care¿ and heartmate iii patient handbook (rev.C) section 6 entitled ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use.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.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

The heartmate 3 instructions for use (ifu) section 5 ¿surgical procedures¿ states that components of the heartmate 3 left ventricular assist system that are supplied sterile are intended for single use only and should not be re-used or re-sterilized.In this case the customer reported that the system controller had been reused from another patient.The manufacturer will provide additional notification to the customer.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: 13795675
• MDR Text Key: 287359751
• Report Number: 2916596-2022-01202
• 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: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/30/2023
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7765884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American