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); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that, when the care provider attempted to plug in the emergency backup battery (ebb) into the controller, the connection did not fit.Upon inspection, a bent pin was found on the right side of the ebb.A new ebb was used.
Additional Manufacturer Narrative
A1-a4: there was no patient involved in this event.The pma# provided is associated with the device¿s most recent approval.Manufacturer's investigation conclusion: the reported event of a bent pin on a backup battery was confirmed.The heartmate 11 volt li-ion backup battery (s/n: (b)(6)) was returned for analysis.Visual inspection confirmed a bent pin (const_lcs_pwr).An attempt was made to connect the battery to a test controller; however, the bent pin prohibited the connection.The pin was straightened in order to undergo functional testing.The battery passed testing without issue.The backup battery was connected to a mock circulatory loop and was able to operate a pump with no alarms active.No alarms were associated with the reported event.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The root cause of the bent backup battery pin was unable to 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 24may2023.The heartmate 3 instructions for use (rev.C) section 2, entitled ¿system operations¿, describes the backup battery installation process.Section 5, entitled ¿surgical procedures¿, also explains how to properly install the backup battery in the system controller.The patient handbook cautions the 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 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; bob.; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 17631638
• Report Number: 2916596-2023-06006
• Device Sequence Number: 6491892
• 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: 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2024

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: 12/03/2024
• Device Model Number: 106128
• Device Lot Number: 8851650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• 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: 08/08/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• 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