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 05/16/2022

Event Type  malfunction  

Event Description

It was reported that the patient continued to have battery fault alarms despite the emergency backup battery (ebb) being replaced on (b)(6) 2022.Log file review confirmed ebb faults caused by the ebb failing the load test.The patient's controller was exchanged.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a backup battery fault alarm was confirmed with the log file retrieved from the returned system controller (serial # (b)(6).The log file captured backup battery fault alarm event on may 14, 15, and 16.The alarm was related to a load test failure.The returned system controller and 11v backup battery was functionally tested using laboratory equipment.An unexpected backup battery fault alarm was unable to be reproduced.A root cause could not be determined during the evaluation.A corrective and preventive action has been initiated to investigate the issue, the returned controller was manufactured prior to the corrective action.Abbott is currently monitoring similar issue.Heartmate 3 patient handbook, rev d, cautions the users to ¿call your hospital contact if you think that, for any reason, any portion of your equipment is not functioning as usual, is broken, or you are uncomfortable with the operation of the equipment.Your hospital contact can check the equipment and order replacements, if needed.Do not try to repair anything yourself.¿ under section 5 ¿alarms and troubleshooting¿ all alarm conditions are addressed including backup battery fault alarms indicating to ¿call your hospital contact as soon as possible for diagnosis and instructions.¿ heartmate 3 instructions for use, rev c, ¿replace any equipment or system component that appears damaged or worn¿.Device history record indicated the device was manufactured in accordance to mfg and qa specifications.System controller (serial # (b)(6) was shipped to the customer on (b)(6)2017.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: 14601731
• MDR Text Key: 293349883
• Report Number: 2916596-2022-11190
• 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,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 6128562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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?: Yes
• Date Device Manufactured: 08/25/2017
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 130 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White