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

Model Number 106531US

Device Problem Failure to Charge (1085)

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

Event Date 04/22/2022

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 went to clinic for a backup battery fault.Reseating the external backup battery(ebb) was attempted as well as changing the ebb, however the alarm was not resolved.The log file was sent for review.The log file confirmed the reported backup battery fault alarms.The alarms may have been caused from the ebb failing the load test.A system controller replacement with software v1.7 would be needed to resolve the issue when it was safe for the patient.Otherwise, there were no notable alarm conditions or parameter changes.The vad was functioning as intended.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported backup battery fault alarms were confirmed via the log file review.The heartmate 3 system controller serial number: (b)(6) was not returned for analysis; however, the log file was submitted for review.A review of the submitted log file showed events spanning approximately 4 hours of data (08:10:12 ¿ 11:54:19 on (b)(6) 2022 per timestamp).The backup battery fault alarms were active from 08:10:12 to 11:25:30, 11:26:09 - 11:34:06, and from 11:34:08 throughout the end at 11:54:19 on (b)(6) 2022 due to a failed load test.The backup battery failed the load test due to the loaded voltage being under the acceptable threshold compared to the unloaded voltage.When the load test failed at 11:26:09 on (b)(6) 2022, the loaded voltage measured ~11.19v, and the unloaded voltage measured ~12.12v.The alarm did not affect the controller's ability to operate the pump at the set speed.There were no other notable alarms active in the log file.Pump operation was not affected.Multiple attempts were made to obtain additional information from the customer regarding the event, asking if the issue was resolved and if any products would be returning; however, no additional information was provided.To date, the system controller (serial number: (b)(6) ) is unavailable for analysis.A root cause for the reported event was unable to be conclusively determined through this analysis however there was an update to the connection between the backup battery and the controller to reduce load test failures occurrences, and this system controller was manufactured prior to that implementation.The device history records were reviewed for the system controller (serial number: (b)(6) ) and was found to pass all manufacturing and qa specifications before being shipped to the customer on 02nov2020.The device history records revealed that the heartmate 11 volt li-ion backup battery gt274476 was shipped with system controller, serial number (b)(6).Heartmate 3 instructions for use section 7 ¿ ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 ¿ ¿alarms and troubleshooting¿, covers all alarms (visual and audible), including backup battery fault and power cable disconnect alarm conditions, and the actions to take if the alarm cannot be resolved.Heartmate 3 instructions for use section 5 ¿ ¿surgical procedures¿, explains how to install the backup battery in the system controller.Additionally, section 2 ¿ ¿system operations¿, explains how to properly replace the backup battery.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.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: 14306281
• MDR Text Key: 290965656
• Report Number: 2916596-2022-10654
• 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,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/26/2022
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7313839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2019
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 101 KG