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

Model Number	109200
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the power module started to show a yellow wrench alarm due to what seemed to be the internal power module backup battery failing.The battery and the power module were disconnected.
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 battery was exchanged and the alarm resolved.
Additional Manufacturer Narrative
Section d5: operator of device corrected manufacturer's investigation conclusion: the reported event of yellow wrench alarm on the power module was unable to be confirmed via evaluation of the returned 12v power module backup battery.The backup battery was visually inspected at the european distribution center (edc) on 30oct2024 and was observed to be physically unremarkable.The battery was forwarded to the product performance engineering (ppe) department for further analysis.The backup battery was connected to a known working test power module for an extended period and no alarms or issues were reproduced.The backup battery was able to support a mock circulatory loop with no issues.The provided information indicated the yellow wrench alarm resolved after the backup battery was exchanged.A root cause for the reported event was not conclusively determined through this analysis.The device history record was reviewed for the 12v power module backup battery, serial number (b)(6).The battery was inspected and accepted into storage on 02aug2022.The heartmate 3 instruction for use (ifu) was available for use at the time of the event.Section 7, entitled ¿alarms and troubleshooting¿, provides instructions on how to identify and resolve power module alarms.The heartmate 3 instructions for use, section 3, entitled ¿powering the system¿, also instructs the user to prevent the power module from being disconnected from ac power longer than 18 hours to prevent damaging the unit¿s backup battery.The heartmate 3 patient handbook 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: 20353742
• Report Number: 2916596-2024-06281
• Device Sequence Number: 15058507
• Product Code: DSQ
• UDI-Device Identifier: 00813024012566
• UDI-Public: (01)00813024012566(10)GW200(17)250630
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 12/02/2024

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: 06/30/2025
• Device Model Number: 109200
• Device Catalogue Number: 109200
• Device Lot Number: GW200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 10/16/2024; 11/22/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 11/01/2024; 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• 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 Sex: Unknown