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

Model Number 106531

Device Problems Display or Visual Feedback Problem (1184); Failure of Device to Self-Test (2937)

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

Event Date 06/05/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient conducted a controller exchange on (b)(6) 2022 after it failed a self-test and the pump running symbol was off.The patient was issued a new spare and logs were taken from the exchanged controller.The logs showed that the pump was running but the controller was not communicating properly.The event log did not capture any unusual events prior to the controller exchange.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of failed a system controller self-test and the pump running symbol being off were not confirmed as the controller was not returned for analysis.The submitted log file contained 256 events spanning approximately 4 days (01jun2022 ¿ 05jun2022 per the timestamp).The data in the log file did not indicate any issues with the system controller.The pump maintained a speed above the low speed limit without issue throughout the log file.Multiple attempts were made to obtain additional information from the customer regarding the event, asking if the patient tolerated the controller exchange if the issues resolved with the controller exchange and its return status, and if there were any other alarms associated with the event; however, no additional information was provided.To date, the system controller (serial number (b)(6) is not available for analysis.As a result, the complaint file will close accordingly and re-open if pertinent information is received.The root cause of the reported events was unable to determine through this analysis.Heartmate 3 instructions for use section 2 ¿ ¿system operations¿ and heartmate 3 patient handbook section 2 ¿ ¿how your heart pump works¿ explain how to properly perform a system controller self-test, and state to press and hold the battery gauge button for five seconds.Heartmate 3 instructions for use section 3 ¿ ¿powering the system¿ and heartmate 3 patient handbook section 3 ¿ ¿powering the system¿ instruct the patient to always connect to the power module or mobile power unit when sleeping or when there is a chance of sleep.A sleeping patient may not hear system controller alarms.The patient handbook and the instructions for use caution the user 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.The device history records were reviewed and the records revealed that the heartmate 3 system controller, serial number (b)(6), was manufactured in accordance with manufacturing and qa specifications.The system controller was shipped to the customer on 13oct2016.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: 14831196
• MDR Text Key: 299073961
• Report Number: 2916596-2022-11631
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 813024013235
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Model Number: 106531
• Device Lot Number: 5685732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2016
• 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: 40 YR
• Patient Sex: Female
• Patient Weight: 134 KG