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

Model Number 106531US

Device Problems Disconnection (1171); Electrical Power Problem (2925)

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

Event Date 06/22/2022

Event Type  malfunction  

Event Description

It was reported that log files captured intermittent backup battery fault alarms on (b)(6) 2022 and (b)(6) 2022 despite the monitor showing 32 months of remaining battery life.It was recommended to reseat the backup battery.An odd string of power cable disconnects and drops in power were also captured while connected to batteries.It was recommended to check the batteries and battery clips for integrity and clean all contacts.

Manufacturer Narrative

Manufacturer's investigation conclusion: incidental findings: atypical power cable disconnect alarms activated due to black power cable faults activating.The reported event of backup battery fault alarms was confirmed via analysis of the submitted log file.The log file contained approximately 6 days of data (22jun2022 ¿ 28jun2022 per the timestamp).Multiple backup battery fault alarms activated on 22jun2022 from 10:43:11 to 10:43:12 and on 27jun2022 from 21:09:12 to 21:24:37 due to backup battery circuit faults activating; the alarms resolved shortly after activating each time.The pump maintained a speed above the low speed limit throughout the log file.The heartmate 3 system controller serial number: (b)(4).Was not returned for evaluation.Technical services recommended reseating the backup battery in the controller and exchanging the backup battery if the issue is not resolved after reseating the product.Multiple requests for additional information were made to determine if the backup battery fault alarms resolved, if any products were exchanged and if any products would be returned for evaluation; however, no response was received.The root cause of the reported event could not be conclusively determined through this analysis.Heartmate 3 patient handbook (rev.D) section 5, entitled ¿alarms and troubleshooting¿, and heartmate 3 instructions for use (ifu) (rev.C) section 7, entitled ¿alarms and troubleshooting¿, cover all alarms (visual and audible), including the backup battery fault and power cable disconnect alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate 3 instructions for use (rev.C) section 2, entitled "system operations", explains how to replace the system controller and how to replace the system controller backup battery.Section 5, entitled ¿surgical procedures¿, also explains how to install the backup battery in the system controller.Heartmate 3 patient handbook (rev.D) section 6, entitled "caring for the equipment", describes how to care for and clean all equipment, including the 14v battery clips and 14v batteries.Section 10, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate 3 lvad, including inspecting/cleaning the contacts on the 14v battery clips and 14v batteries.The heartmate 3 patient handbook (rev.C) cautions 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)(4), was manufactured in accordance with manufacturing and qa specifications.The heartmate 3 system controller was shipped to the customer on (b)(6) 2022.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: 15068810
• MDR Text Key: 303058571
• Report Number: 2916596-2022-12408
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 8388631
• 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: 03/06/2022
• 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: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American