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

Model Number 106531INT

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 07/08/2022

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 the customer reported that the pump running led on the system controller had dimmed to a point where it could not be seen clearly.The system controller was exchanged.There were no reported functional issues with the system controller performance.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a dim green pump led was confirmed via product testing.The heartmate 3 system controller (serial #: (b)(6) was returned for analysis and a log file was downloaded for review spanning approximately 5 days (b)(6) 2022 ¿ (b)(6) 2022, (b)(6) 2022 per timestamp).There were no notable alarms in the log file.Pump operation was not affected.The heartmate system controller was able to pass all testing and had no issues in performance.A dim green pump led was observed after the unit was powered on; this did not affect testing results.The unit was able to operate on a mock loop without issues.The root cause of the reported event was unable to be determined in this analysis.The device history records were reviewed and the records revealed the heartmate iii system controller (serial#: (b)(6) 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.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.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.

• 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: 15107118
• MDR Text Key: 296665773
• Report Number: 2916596-2022-12488
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/26/2022
• Device Model Number: 106531INT
• Device Lot Number: 6957460
• 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: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2019
• 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: 36 YR
• Patient Sex: Male
• Patient Weight: 120 KG