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

Model Number	106762
Medical Device Problem Codes	Disconnection (1171); Mechanical Problem (1384); Electrical Power Problem (2925); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had several power cable disconnects and low voltage advisories that were of unknown origin.Damage to the bend relief portion of the system controller power cables was also observed with green sludge showing through.The system controller was exchanged.Log file analysis confirmed unusual power cable disconnects.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of atypical power cable disconnect and low voltage alarms was confirmed via the log file submitted for review.However, the investigation could not confirm the damage to the power cables, as there were no images submitted to this complaint.A review of the submitted log file contained 240 events spanning approximately 9+ days ((b)(6) 2022 per timestamp).The controller recorded intermittent atypical power cable disconnect events that were not associated with a power source exchange and were due to power cable faults occurring on both power cables when the system controller was connected to battery power.These events accompany the power cable disconnect alarm.Low voltage advisory alarms were also recorded and caused by normal battery depletion.Pump operation was not affected and maintained speeds above the lsl throughout the log file.The system controller pcx-19120 was not returned for analysis, as it was discarded.Due to the controller being unavailable for analysis, the complaint file will be closed without further action.The exact cause for the atypical events captured in the log file and the reported damage to the controller power cables was not determined through this investigation.The device history records were reviewed for the system controller (serial number: (b)(4) and was found to pass all manufacturing and quality assurance specifications before being shipped to the customer on 30jun2020.Heartmate ii instructions for use (ifu) section 2 entitled ¿system operations¿ and heartmate ii patient handbook section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms including power cable disconnect alarm conditions, and the actions to take if the alarms cannot be resolved.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• 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: 14948579
• Report Number: 2916596-2022-11894
• Device Sequence Number: 17322096
• Product Code: DSQ
• UDI-Device Identifier: 00813024013013
• UDI-Public: 00813024013013
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/07/2022

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: 02/26/2023
• Device Model Number: 106762
• Device Catalogue Number: 10005080
• Device Lot Number: 7478689
• 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: 06/15/2022
• Initial Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2020
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 140 KG