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

Model Number 106531US

Device Problems Mechanical Problem (1384); Electrical Power Problem (2925)

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

Event Date 07/07/2023

Event Type  malfunction  

Event Description

It was reported that the patient noted several low voltage alarms as of 07jul2023 with shortness of breath and dizzy spells.The white portion of the power cable was a bit loose at the junction of the controller.The patient and their wife proceeded to change the primary controller to the backup controller.The looseness at the controller junction resolved.The patient was stable at home.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of low voltage alarms occurring as of 07jul2023 and a loose white portion of the power cable at the junction of the controller were not confirmed.The system controller (serial number unknown) was not returned for analysis, and no log files from the controller that was in use within the jul2023 timeframe were provided.Questions regarding the controller and log file information were asked multiple times, and no further information was able to be provided.Per additional information, the issues resolved upon exchanging the system controller.The root causes of the reported events were unable to be conclusively determined through this analysis.The serial number of the system controller was not provided.The heartmate 3 patient handbook (rev.D, section 5 ¿alarms and troubleshooting¿) instructs users on how to identify and resolve alarms that sound from their system controller, including alarms associated with low voltage conditions.The heartmate 3 patient handbook (rev.D, section 10 ¿safety checklists¿) instructs users to regularly inspect their equipment, including their system controllers, and to avoid using equipment that appears damaged.Users are encouraged to replace any equipment that appears damaged.The heartmate 3 patient handbook (rev.D, section titled "emergency contact list") cautions 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 19213873
• MDR Text Key: 341436454
• Report Number: 2916596-2024-02521
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106531US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• 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: Male
• Patient Weight: 83 KG