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

Model Number	106128
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the white plastic wrap of the 11volt lithium-ion battery was broken.
Additional Manufacturer Narrative
No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigaiton is complete.
Additional Manufacturer Narrative
Correction to g3: the initial mdr was submitted with a g3 date of 02aug2023; the correct g3 is 27jul2023.Manufacturer's investigation conclusion: the reported event of damage to the battery sleeve on the 11v backup battery was confirmed via the customer submitted photo.The 11v backup battery (serial #: (b)(6)) was not returned for analysis.Additional provided information stated that the product will not be returned.The root cause for the reported event was unable to be conclusively determined through this analysis.The receiving inspection documents were reviewed for the 11v backup battery (serial #: (b)(6)) and the battery was found to pass inspection.Heartmate iii instructions for use section 8 entitled ¿equipment storage and care¿ heartmate iii patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for, maintain, and store the equipment for proper use.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.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
Additional information was received that the damage was an out of box issue.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of damage to the battery sleeve on the 11v backup battery was confirmed via the customer-submitted photos.To date, the 11v backup battery (serial #: (b)(6)) has not returned to abbott for evaluation.The root cause of the reported event was unable to be conclusively determined through this analysis.The receiving inspection documents were reviewed for the 11v backup battery (serial #: (b)(6)) and the battery was found to pass inspection.Heartmate iii instructions for use section 8 entitled ¿equipment storage and care¿ heartmate iii patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for, maintain, and store the equipment for proper use.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.
Additional Manufacturer Narrative
Section d3: correction.Section d4 (primary unique device identification (udi) number): correction.Section g1: correction.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 17573370
• Report Number: 2916596-2023-05846
• Device Sequence Number: 8267604
• Product Code: DSQ
• UDI-Device Identifier: 00813024011255
• UDI-Public: (01)00813024011255(17)251031(11)221019
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/03/2024

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: 10/31/2025
• Device Model Number: 106128
• Device Catalogue Number: 106128
• Device Lot Number: 8737237
• Was Device Available for Evaluation?: No
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 11/09/2023; 07/31/2024; 10/22/2024; 12/03/2024
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 11/13/2023; 08/27/2024; 11/13/2024; 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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