MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER; Ventricular (assist) bypass

Model Number 106531INT

Device Problem Mechanical Problem (1384)

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

Event Date 02/02/2024

Event Type  malfunction  

Event Description

It was reported that the controller was exchanged due to the screw on the black connector being broken.

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 report of a broken black connector nut was confirmed through the evaluation of the submitted photo.A specific cause for the damage cannot be conclusively determined through this evaluation.A photo of the damaged screw nut was submitted, which revealed a lengthwise crack in the nut.The device history records were reviewed and the records revealed the heartmate 3 system controller (serial number: (b)(6) was manufactured in accordance with manufacturing and quality assurance specifications.Heartmate iii instructions for use (ifu) section 8 entitled ¿caring for the equipment¿ 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.Heartmate iii patient handbook and heartmate iii instructions for use (ifu) caution 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.

Event Description

Additional information was received that no log files were available for analysis and no alarms were associated with the event.There was no patient symptoms were noted during the controller exchange.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18753659
• MDR Text Key: 335946596
• Report Number: 2916596-2024-00801
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106531INT
• Device Lot Number: 8248202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2021
• 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 Sex: Female