MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 11 VOLT LI-ION BACKUP BATTERY; VENTRICULAR (ASSISST) BYPASS

Model Number	106762
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involved.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the emergency backup battery (ebb) out of box had visible bent pins before being placed in the system controller.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of bent pins in the backup battery was confirmed via evaluation of the returned backup battery.Visual inspection of the returned 11v backup battery (serial number: (b)(6) revealed that pins 11, 10 and 1 were bent.The bent pins were straightened for testing.After straightening the bent pins, the backup battery was functionally tested.The battery was installed in a test system controller and successfully operated in a mock circulatory loop without any issues or atypical alarms produced.The controller was disconnected from external power; however, the backup battery was unable to support the system as the battery was returned with depleted charge.The backup battery was then fully charged by connecting the controller to a power module.After fully charging the backup battery, the battery was functionally tested again and found to operate as intended during analysis.The battery was installed in a test system controller and successfully operated in a mock circulatory loop without any issues or atypical alarms produced.The controller was then disconnected from external power and the battery supported the pump without any issues.The root cause of the reported event could not be conclusively determined through this analysis.Battery inspection data was reviewed for the 11v backup battery, serial number (b)(6), revealing that the battery passed all inspection testing.The battery was shipped to the customer on 22apr2021.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 heartmate 3 patient handbook and the heartmate 3 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 11 VOLT LI-ION BACKUP BATTERY
• Common Device Name: VENTRICULAR (ASSISST) 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: 12450124
• Report Number: 2916596-2021-04811
• Device Sequence Number: 11646851
• Product Code: DSQ
• UDI-Device Identifier: 00813024011255
• UDI-Public: 00813024011255
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2024
• Device Model Number: 106762
• Device Catalogue Number: 106128
• Device Lot Number: 7869811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown