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

Model Number 106531INT

Device Problems Display Difficult to Read (1181); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a white line on controller screen.However, the patient passed away on (b)(6) 2021 due to multi organ failure so the controller will not be returned.

Manufacturer Narrative

The patient's death has already been reported under mfr # 2916596-2021-04994.Manufacturer's investigation conclusion: the reported event of a line on the backup system controller was confirmed.The submitted photograph showed a single vertical white line in the controller¿s lcd display.The line did not prevent information from being displayed or read from the display.The customer reported that the controller would not be returned for evaluation.The root cause of the reported event could not be conclusively determined through this analysis.Lines in the lcd display of the system controller is a known issue related to the lcd display screen and a corrective and preventative action (capa) has been implemented to reduce the occurrences.The system controller associated with this event, serial number (b)(6) , was manufactured with the implementation of the capa.Similar events will continue to be tracked and monitored.Per the labeling on the packaged part (model # 106531 int), the manufacturing date was 31jul2020; the expiration date was 31jul2023.The firmware/software was ver 1.6.0.The system controller was shipped to the customer with on (b)(6) 2020.The heartmate 3 lvas patient handbook section 2 ¿how your heart pump works¿ and the heartmate 3 lvas instructions for use sec 2 ¿system operations¿ explain the system controller user interface, including the display screen and all buttons, lights and symbols.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: 12484745
• MDR Text Key: 271798759
• Report Number: 2916596-2021-04992
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Model Number: 106531INT
• Device Lot Number: 7635412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2020
• 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
• Patient Outcome(s): Life Threatening; Death
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 47 KG