MAUDE Adverse Event Report: THORATEC CORPORATION SYSTEM CONTROLLER, HM 3, LOW FLOW 2.0; VENTRICULAR (ASSIST) BYPASS

Model Number	106531LF2
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Event or Problem Description
Related manufacturer report number: 2916596-2023-06963.It was reported that the patient's pump turned off.The patient recalled waking up and changing their batteries, but the pump did not restart and suspected it had been off for 30 minutes.The patient was brought to the hospital for medical management.It was later reported that no cause for the pump stop had been identified.The patient's left ventricular assist device (lvad) was decommissioned on (b)(6) 2023, and the patient remained off of lvad support as of (b)(6) 2023.The plan of care was medical management.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported pump stop was not able to be determined.The system controller, serial number (b)(6), was not returned for evaluation and no log files were provided for review.Multiple attempts were made to obtain additional information (including the log files) from the customer regarding the event; however, no additional information was provided, and no additional follow-up attempts will be performed.A specific cause for the reported event could not be conclusively determined through this evaluation.The device history records were reviewed, and the records revealed the system controller was manufactured in accordance with manufacturing and quality assurance specifications.Heartmate 3 patient handbook under section 5 ¿alarms and troubleshooting¿ and heartmate 3 instructions for use, under section 7 ¿alarms and troubleshooting¿ explain all alarms and the proper actions to take if the alarms cannot be resolved.Heartmate 3 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.

• Brand Name: SYSTEM CONTROLLER, HM 3, LOW FLOW 2.0
• 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: 17861981
• Report Number: 2916596-2023-06964
• Device Sequence Number: 6135204
• Product Code: DSQ
• UDI-Device Identifier: 05415067031105
• UDI-Public: 05415067031105
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/20/2024

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: 10/23/2024
• Device Model Number: 106531LF2
• Device Lot Number: 8855779
• 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: 09/18/2023
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 66 KG