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

Model Number	103696
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2023
Type of Reportable Event	Malfunction
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
It was reported that when the patient changed power sources, they heard a continuous alarm.A review of the log files by technical services found power cable disconnect alarms that occurred when the patient was connected to the power module and a battery at the same time.The alarm resolved by itself.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of unexpected power cable disconnect alarm event was confirmed via log file analysis.The log file captured power cable disconnect alarm events while the white power cable was connected to the power module (via the 14v power module patient cable) and the black power cable was connected to the 14v battery/clip.The intermittent alarm event was captured at the end of the log file.All other power cable disconnect alarm event were related to power exchanges.Additional information communicated that the reported alarm issue resolved by itself.System controller (serial # (b)(6)) will not be returning for an evaluation.The unexpected power cable disconnect alarm captured in the log file could not be determined through this evaluation.To date, the system controller associated with the event was unavailable for an evaluation.Device history record indicated the device was manufactured in accordance to mfg and qa specifications.Patient handbook operating manual (section 8), instructions for use (section 12.4) covers all alarms (visual and audible) on the system controller and what action should be performed when they do occur.Under low voltage advisory and low voltage hazard alarms.Low voltage advisory alarm is a yellow battery symbol with 1 beep every 4 seconds.Low voltage is a red battery with continuous audio tone.Also, continuous audio tone, but no warning light and no green power symbol indicate the system controller is not receiving power.Under power cable disconnected.One of the power leads is disconnected.Check for loose power leads.If on pm power, check that power lead is not disconnected or damaged.Check that the system controller power lead is damaged.No further information was provided.The manufacturer is closing the file on this event.

• 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: 16611231
• Report Number: 2916596-2023-01462
• Device Sequence Number: 14730002
• 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): 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): 03/29/2023

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: 01/31/2021
• Device Model Number: 103696
• Device Catalogue Number: 103696
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2018
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 72 KG