MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP; VENTRICULAR (ASSIST) BYPASS

Model Number	103696
Medical Device Problem Codes	Disconnection (1171); Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.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 patient received a pump replacement from heartmate ii (hmii) to heartmate 3 (hm3) due to suspected driveline disconnection.Speed was decreased and hmii blood pump stopped on (b)(6)2024.It then was replaced the pump with hm3 with extracorporeal membrane oxygenation (ecmo) operating.There was hemodynamic failure due to the pump stop.The patient remained hospitalized.The reason of driveline disconnect could not be confirmed.
Additional Manufacturer Narrative
Section h6: medical device problem code corrected manufacturer's investigation conclusion: the heartmate ii system controller ep (serial number (b)(6) was returned for evaluation following the reported event of a suspected driveline disconnection and pump stop.A log file was extracted for review and contained data spanning 7 minutes (day 1934 hour 18 minute 8 ¿ day 1934 hour 18 minute 15, per timestamp).Starting from the beginning of the log file, low speed advisories, low speed hazards, and pump stops were captured.The low speed and pump stop events did not resolve before the driveline was disconnected on day 1934 hour 18 minute 14.The system controller was functionally tested and was found to perform as intended.Per additional information, the patient underwent an hm2 to hm3 pump exchange to resolve the issue.The root cause for the reported event was determined to be related to the driveline of the pump and will be addressed via the returned hm2 pump¿s investigation.The system controller was not correlated to the root cause of the reported event.Heartmate ii instructions for use (rev.A) section 3 entitled ¿powering the system¿ and heartmate ii patient handbook (rev.B) section 3 entitled ¿powering the system¿ instructs the user not to bend, twist, or kink the power leads of the system controller and addresses how long the 14v batteries provide power to the system controller.Heartmate ii instructions for use (rev.A) section 8 entitled ¿equipment storage and care¿ and heartmate ii patient handbook (rev.B) 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.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP
• 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: 20871845
• Report Number: 2916596-2024-07781
• Device Sequence Number: 15679744
• Product Code: DSQ
• UDI-Device Identifier: 00813024010630
• UDI-Public: (01)00813024010630(17)211120
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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: 11/20/2021
• Device Model Number: 103696
• Device Catalogue Number: 103696
• Device Lot Number: 6746855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2018
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 55 KG