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

Model Number 106531US

Device Problems Alarm Not Visible (1022); Display or Visual Feedback Problem (1184); Insufficient Information (3190)

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

Event Date 06/01/2022

Event Type  malfunction  

Event Description

It was reported that the patient's log files were sent to technical services to be reviewed for concerns of an alarm that occurred on (b)(6) 2022.At the time of the alarms, the system controller lights did not light up.

Manufacturer Narrative

No additional informaiton was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the controller not producing visual signals while a continuous sound/alarm was active was not confirmed.The submitted log file contained approximately 5 hours of data ((b)(6) 2022 from 4:21:02 to 9:12:16 per the timestamp).The log file data did not indicate any issues with the system controller.The reported alarm was not captured in the log file despite the date and time, on which the reported alarm activated, being captured in the log file; it was reported that the alarm activated on (b)(6) 2022 at approximately 9:00.There were no notable alarms throughout the log file.The pump maintained a speed above the low speed limit throughout the log file.The heartmate 3 system controller (serial number: (b)(6) ) was not returned for evaluation.Additional information provided stated that the alarm resolved by itself and that the cause of the alarm was unknown.Although not confirmed, it appears that the event of the controller not producing visual signals was not observed again.The root cause of the reported event could not be conclusively determined through this analysis.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 quality assurance specifications.The heartmate 3 system controller was shipped to the customer on 08oct2019.Heartmate 3 patient handbook section 5, entitled ¿alarms and troubleshooting¿, and heartmate 3 instructions for use section 7, entitled ¿alarms and troubleshooting¿, cover all alarms (visual and audible), and the actions to take if the alarms cannot be resolved.Heartmate 3 patient handbook section 10, entitled ¿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.Heartmate 3 patient handbook 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

Related manufacturer report number: 2916596-2022-11636.

• 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: 14698872
• MDR Text Key: 298964016
• Report Number: 2916596-2022-11616
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/30/2022
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7181635
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2019
• 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 Sex: Male
• Patient Weight: 73 KG