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

Model Number 106531US

Device Problems Misconnection (1399); Communication or Transmission Problem (2896)

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

Event Date 01/13/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that no communication could be established between the system controller and system monitor (connections to 3 monitors were attempted).A controller exchange was performed and the connection resumed normally.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of the system controller not communicating with a monitor and the controller¿s serial number labeling being illegible were not confirmed.The system controller (serial number (b)(6)) was not returned for analysis, and no log files were associated with the reported event.The root causes of the reported events were unable to be conclusively determined through this analysis.The device history records for the system controller, serial number (b)(6), were reviewed and showed the device was manufactured in accordance with manufacturing and qa specifications.The heartmate 3 patient handbook 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 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.

Event Description

It was also reported that the serial number was rubbed off of the controller but the nurse thought it was (b)(6).

• 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: 13347252
• MDR Text Key: 287546447
• Report Number: 2916596-2022-00358
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2022
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7379400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 01/25/2022
• Supplement Dates Manufacturer Received: 03/01/2022
• Supplement Dates FDA Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2019
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 69 KG