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

Model Number	106128
Medical Device Problem Codes	Mechanical Problem (1384); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G3: there was no patient involved in this event.The pma# provided is associated with most recent approval.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 upon removing the backup battery from the box, bent pins were noted.There were no alarms, and the battery was not used.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a bent backup battery pin was confirmed via inspection of the returned backup battery.Visual inspection of the returned backup battery revealed that pin 10 was bent.The bent pin was straightened for testing.After straightening the bent pin, the backup battery functioned as intended without any issues.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 and the backup battery supported the pump without any issues.Inspection data for the backup battery was reviewed and showed to passing inspection testing prior to being shipped to the customer.A root cause for the damage to the pins could not be conclusively determined.Battery inspection data was reviewed for the 11v backup battery revealing that the battery passed all inspection testing.The battery was shipped to the customer on 28jun2023.Heartmate ii instructions for use section 2 "system operations" explains how to replace the system controller backup battery.Additionally, section 5 ¿surgical procedures¿, also explains how to install the backup battery in the system controller.The heartmate ii patient handbook and the heartmate ii 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 (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: 17665486
• Report Number: 2916596-2023-06081
• Device Sequence Number: 20395045
• Product Code: DSQ
• UDI-Device Identifier: 00813024011255
• UDI-Public: 00813024011255
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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: 12/23/2024
• Device Model Number: 106128
• Device Lot Number: 8933236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2023
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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