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 04/18/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient came in with concerns regarding emergency backup battery (ebb) fault alarms.The battery had 29 months left, the ribbon was intact, and there was no obvious damage to the driveline or pocket controller components.Log file review recorded an ebb fault event on (b)(6) 2022 at 11:20:06 after the system controller attempted a load test.The pocket controller was a v.1.6.And the vad coordinator swapped the primary controller to a v.1.7.The alarms resolved after exchange, and the patient tolerated the controller exchange well.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of backup battery fault alarms was confirmed via log file analysis.The heartmate 3 system controller (serial number: (b)(6)) was not returned for analysis; however, a log file was submitted for review and showed events spanning approximately 2 days ((b)(6) 2022 ¿ (b)(6) 2022 per timestamp).Backup battery fault alarms, due to a backup battery load test failure, were intermittently active on (b)(6) 2022 from 11:20:06 ¿ 13:45:21.The backup battery failed the load test due to the loaded voltage being under the acceptable threshold as compared to the unloaded voltage.When the load test first failed, the loaded voltage measured ~11.31v and the unloaded voltage measured ~12.14v.Pump operation was not affected by these alarms.There were no other notable alarms active in the log file.Additional information provided on 25apr2022 stated that the alarms resolved with the controller exchange, and that no product would be returned for evaluation.A root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed and the records revealed the heartmate 3 system controller (serial number: (b)(6)) was manufactured in accordance with manufacturing and qa specifications.Customer order was shipped on 04sep2019.Heartmate iii instructions for use section 7 entitled ¿alarms and troubleshooting¿ and heartmate iii patient handbook section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms, including backup battery fault alarms.Heartmate iii instructions for use section 8 entitled ¿equipment storage and care¿ and heartmate iii patient handbook section 6 "caring for the equipment" describes how to care for and clean all equipment including the system controller power cables and power cable connectors.Heartmate iii patient handbook and heartmate iii instructions for use (ifu) under section 3, entitled ¿powering the system¿, describes the various ways to power the heartmate ii lvas.These sections explain how to properly switch between power sources.Heartmate iii patient handbook and heartmate iii instructions for use (ifu) 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: 14208436
• MDR Text Key: 290155324
• Report Number: 2916596-2022-10513
• 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: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2022
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7154543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2019
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American