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

Model Number 106531INT

Device Problem Display Difficult to Read (1181)

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

Event Date 04/22/2022

Event Type  malfunction  

Event Description

It was reported that there was a defective display on the system controller.The display contained unusual vertical stripes and information in the lower part was not readable.The system controller was exchanged with a new one.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of vertical lines in the lcd screen was confirmed.The system controller, serial number (b)(6), returned for analysis.The controller then underwent testing and passed.No atypical alarms were produced during testing.Following preliminary testing, the lcd screen from the controller was swapped with a functional lcd.This resolved the lines in lcd issue.The line in the lcd is a known issue related to the lcd itself.This did not affect the controller¿s ability to display messages or provide power to the pump.The controller was able to support pump function for extended period of time.The root cause for the line in the lcd was conclusively determined to be due to an issue with the lcd display; however, a further root cause was not able to be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The patient handbook and instructions for use (ifu) also 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.Heartmate 3 instructions for use section 8-¿equipment storage and care¿ and heartmate 3 patient handbook section 6-¿caring for the equipment¿ explain how to properly take care and maintain the integrity of the system controller.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: 14212510
• MDR Text Key: 290153879
• Report Number: 2916596-2022-10625
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2023
• Device Model Number: 106531INT
• Device Lot Number: 7740537
• 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: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2020
• 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