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

Model Number 106531US

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2020

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 the patient's controller had a broken display screen.They were unable to view pump numbers or see any display on the controller.The patient was thenon the power module and the screen and numbers were within normal limits.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of difficulty in reading device parameters on lcd screen was confirmed.The log file spanned approximately 16 days ((b)(6) 2020 to (b)(6) 2020 per the timestamp).There were no events related to the log file.Initial evaluation of the returned hm3 system controller, serial (b)(6), revealed a damaged lcd screen that made device parameters difficult to read.The lcd was replaced with a test lcd resolving the issue.The controller was functionally tested and was connected to a mock circulatory loop for an extended period of time without any issue.The damaged lcd did not affect the functionality of the controller.A root cause of the reported event was not determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.(b)(6) was shipped to the customer on 31jul2018.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.Heartmate iii instructions for use section 8 entitled ¿equipment storage and care¿ and heartmate iii patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for, maintain, and store the equipment for proper use.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
• MDR Report Key: 11067542
• MDR Text Key: 223728875
• Report Number: 2916596-2020-06080
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2021
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 6468192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 101