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

Model Number 106531US

Device Problems Electrical /Electronic Property Problem (1198); Electrical Power Problem (2925)

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

Event Date 03/05/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of controller fault alarms was unable to be confirmed.The heartmate 3 system controller (serial number: (b)(4) was not returned for analysis; however, a log file was submitted for review.A review of the submitted log files showed events spanning approximately 3 days (05mar2022 ¿ 07mar2022 per timestamp).Lvad internal faults were active from 05mar2022 at 19:48:28 ¿ 07mar2022 at 10:49:34.The alarms did not clear in the log file.These alarms were a result of an esd event which is covered under manufacturer report number 2916596-2022-01559.There were no other notable alarms active in the log file.Additional information provided on 09mar2022 stated that no product will be returning.Additional information stated that the patient had a controller fault alarm that was only revealed when connecting to the system monitor.The lvad internal fault alarms may result in a controller fault alarm; however, after a review of the log file, there were no controller fault alarms active.The root cause of the reported event was unable to be conclusively determined through this investigation.Heartmate iii patient handbook (rev.C) section 7 entitled ¿alarms and troubleshooting¿ and heartmate iii patient handbook (rev.C) section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms including controller fault alarms.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.The device history records were reviewed for the system controller (serial number: hsc-062256) and was found to pass all manufacturing and qa specifications before being shipped to the customer no further information was provided.The manufacturer is closing the file on this event.

Event Description

Related manufacturing number: 2916596-2022-11196 this information was previously reported under manufacturer report number 2916596-2022-11196.It was reported that the patient had a controller fault alarm.The alarm was only revealed when hooked up to the monitor.The patient denied having audible or visual alarm on the controller.Log files were sent and analysis revealed that the electrostatic discharge event had stopped the pump momentarily and then restarted.In order to clear the alarm the patient's driveline was removed from the controller and reinserted.The patient tolerated it well with some light-headedness and a strange sensation in the chest.The pump resumed normal function with no alarm after the driveline was reinserted.

• 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: 15051888
• MDR Text Key: 304720345
• Report Number: 2916596-2022-12210
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 6338549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2018
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Weight: 73 KG