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	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initially reported under mfr # 2916596-2024-04326.Manufacturer's investigation conclusion: the reported event of a red battery and yellow wrench advisory alarm was confirmed via evaluation of the returned 12v power module backup battery.The returned backup battery, serial number (b)(6), was inserted into a test power module and upon powering on the system, a yellow wrench advisory and red battery alarm activated.Evaluation of the battery revealed that it was in a depleted state.Despite charging the battery for an extended period of time, the yellow wrench advisory and red battery alarms were still active.Further evaluation was not performed as the sealed lead acid (sla) batteries posed a chemical hazard and its encapsulation prevented further access to sub-assemblies.The backup battery was not expired at the time of the reported event.The provided information indicated the alarms resolved after the power module backup battery was exchanged.A root cause for the reported event was not conclusively determined through this analysis.A manufacturing analysis has been initiated to further investigate this issue.The device history record was reviewed for the 12v power module backup battery, serial number (b)(6).The backup battery was inspected and accepted into storage on 07mar2023.The heartmate 3 instruction for use and heartmate power module instructions for use 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 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.
Event or Problem Description
It was reported that the new power module battery was not working.The battery was disconnected for 10+ minutes and reconnected, a system test was attempted, however the red battery and yellow wrench alarms still showed.The power module backup battery was exchanged.It was additionally reported that the serial number of the power module was unknown as the clinic had received 5 new power modules and the power module was not connected to a patient.It was noted that all of the power modules now had working batteries.

• 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: 20495284
• Report Number: 2916596-2024-06605
• Device Sequence Number: 4096029
• Product Code: DSQ
• UDI-Device Identifier: 00813024012566
• UDI-Public: (01)00813024012566(17)260131
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2024

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: 01/31/2026
• Device Model Number: 109200
• Device Catalogue Number: 109200
• Device Lot Number: GX047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• 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: 09/30/2024
• Initial Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2023
• 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