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

Model Number 106531INT

Device Problem No Display/Image (1183)

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

Event Date 03/15/2022

Event Type  malfunction  

Event Description

It was reported that no alarms were appearing on the system controller's screen.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 no alarms appearing on the system controller was unable to be confirmed.The heartmate 3 system controller (s/n: (b)(6) was not returned for analysis.Provided information stated that the controller displayed a brown screen without any alarms.Additionally, the product was sent to the wrong location and lost in transit.No additional documents or pictures were provided.A root cause for the reported event was unable to be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.Heartmate 3 patient handbook section 2 - ¿how your heart pump works¿ and heartmate 3 instructions for use (ifu), section 2 - ¿system operations¿ explain the system controller user interface, including the display screen and all buttons, lights, and symbols.Heartmate 3 patient handbook section 5 - ¿alarms and troubleshooting¿ and heartmate 3 instructions for use (ifu), section 7 - ¿alarms and troubleshooting¿ cover all alarms (visual and audible), including the backup battery fault alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate 3 patient handbook 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.

• 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: 13928767
• MDR Text Key: 288044160
• Report Number: 2916596-2022-01817
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/22/2022
• Device Model Number: 106531INT
• Device Lot Number: 6863555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2019
• 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: 71 YR
• Patient Sex: Female