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

Model Number	103696
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: incidental findings: fluid ingress system controller serial # (b)(6) was returned for an evaluation as part of a pump exchange and an evaluation was performed.No reported issue with the system controller.The device passed the functional test procedure, confirming that all visual and audible alarms activated when they were induced.Log file analysis did not capture data that could be correlated to the system controller.The motor stopped command appears to have been initiated via the system monitor at day 2009 hour 4 minute 35 and the system stopped.The driveline disconnected not long after.The driveline disconnected event appeared to be related to the reported pump exchange.Device history record indicated the device was manufactured in accordance to mfg and qa specifications.Patient handbook rev.D rev.F (section 8), instructions for use rev.D covers all alarms (visual and audible) on the system controller and what action should be performed when they do occur.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the patient underwent a pump exchange and the system controller was exchanged.Related regulatory reference report mfr # (b)(4).

• Brand Name: 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 18563732
• Report Number: 2916596-2024-00549
• Device Sequence Number: 15135017
• Product Code: DSQ
• UDI-Device Identifier: 00813024010630
• UDI-Public: 00813024010630
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2024

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: 05/31/2018
• Device Model Number: 103696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2015
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 85 KG