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

Model Number	106128
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient's primary controller's emergency backup battery (ebb) was unable to charge since left ventricle assist device (lvad) implantation.Ebb was reseated without resolution.The defective ebb was exchanged with a new ebb.The new battery was able to charge.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion.The reported event of the 11v backup battery being unable to charge was unable to be confirmed.The heartmate iii system controller (serial number: (b)(6) was not returned for analysis; however, the 11v backup battery (serial number: (b)(6) was returned for analysis.The battery was connected to a test system controller and was able to charge and support a mock loop without issue.The backup battery was able to function as intended.Additional information provided on 16nov2021 stated that the new backup battery was able to be charged.The root cause of the reported event was unable to be conclusively determined through this investigation.Heartmate iii instructions for use, rev.C, section 7 entitled ¿alarms and troubleshooting¿ and heartmate iii patient handbook, rev.C, section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms including backup battery fault alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate iii instructions for use, rev.C, section 8 entitled ¿equipment storage and care¿ and heartmate iii patient handbook, rev.C, section 6 entitled ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use including how to ensure that the backup battery is properly installed.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.The device history records were reviewed for the system controller (serial number:(b)(6) and for the emergency backup battery (serial number: (b)(6) and were found to pass all manufacturing and qa specifications before being shipped to the customer.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: 12972526
• Report Number: 2916596-2021-06884
• Device Sequence Number: 4452602
• Product Code: DSQ
• UDI-Device Identifier: 00813024011255
• UDI-Public: 813024011255
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2022

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: Lay User/Patient
• Device Expiration Date: 08/13/2024
• Device Model Number: 106128
• Device Lot Number: 8113756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2021
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White