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

Model Number 106531INT

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

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

Event Date 07/07/2022

Event Type  malfunction  

Event Description

It was reported that the patient presented to the clinic on (b)(6) 2022 with broken black and white power cables.The patient also had low voltage alarms despite being connected to fully charged batteries.The system controller was exchanged.

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 reported event of damage to the black and white power cables of the system controller and the reported low voltage events were not confirmed.The heartmate 3 system controller (serial #: (b)(6)) was not returned for analysis and no log files were submitted for review.Multiple attempts were made to obtain additional information regarding the product return; however, no additional information was provided.If the product is returned in the future, the event will be updated, and product analysis will be performed at that time.The root causes of the reported events were unable to be determined in this analysis.The device history records were reviewed and the records revealed the heartmate 3 system controller was manufactured in accordance with manufacturing and qa specifications.Heartmate iii instructions for use section 7 ¿ ¿alarms and troubleshooting¿ and heartmate iii patient handbook section 5 ¿ ¿alarms and troubleshooting¿ explains how to properly interpret and troubleshoot all alarms, including low voltage advisory alarms.Heartmate iii instructions for use section 8 ¿ ¿equipment storage and care¿ and heartmate iii patient handbook section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment.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.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: 15114029
• MDR Text Key: 303085121
• Report Number: 2916596-2022-12189
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Model Number: 106531INT
• Device Lot Number: 6368404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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