MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE® SEALED LEAD ACID BATTERY; VENTRICULAR (ASSIST) BYPASS

Model Number	109200
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
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 the patient was traveling across the country and attempted to plug the power module into the auxiliary jack of their truck with the abbott car adapter.Despite the power module being plugged into the auxiliary jack, the power module's backup battery was not charging ( (b)(6) ) and discharged (died).The discharged backup battery was replaced with a new backup battery ( (b)(6) ) which also would not charge.The patient made multiple attempts to reinstall the backup battery and called the site to attempt troubleshooting.The replacement backup battery ( (b)(6) ) still would not charge with troubleshooting and the patient was sent another replacement backup battery by customer service.
Additional Manufacturer Narrative
The heartmate power module 12v backup battery, serial number (b)(6), was determined to be unrelated to the reported event of 12v power module backup battery, serial number (b)(6), not charging.The backup battery, serial number (b)(6), was not returned for evaluation and no other files were submitted.Per the hf complaint procedure (rev.Bg), a device history record review was not performed as the returned device performed as intended during evaluation.The heartmate 3 instruction for use (rev.A) and heartmate power module instructions for use (rev.C) were available at the time of the event.Heartmate 3 instruction for use, section 3, entitled ¿powering the system¿, and heartmate power module instructions for use, section 2, entitled ¿setting up the power module (pm) prior to use¿, provide instructions on how to install the power module backup battery and general use of the power module.The heartmate 3 instructions for use, section 8, entitled ¿equipment storage and care¿ explains how to care for and clean the power module.The heartmate 3 patient handbook (rev.D) which was available for use at the time of the event, 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® SEALED LEAD ACID 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: 20015607
• Report Number: 2916596-2024-05384
• Device Sequence Number: 20673663
• Product Code: DSQ
• UDI-Device Identifier: 00813024012566
• UDI-Public: (01)00813024012566(17)250831
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: Lay User/Patient
• Device Expiration Date: 08/31/2025
• Device Model Number: 109200
• Device Catalogue Number: 109200
• Device Lot Number: GW258
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White