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

Model Number	106762
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient had system controller faults and damage to white lead coming off pocket controller.The controller was changed out.Patient international normalized ratio is normal and the patient is stable.
Additional Manufacturer Narrative
Multiple attempts were made to obtain additional information from the customer regarding the event (including device serial number); however, no additional information was provided.Manufacturer's investigation conclusion: the reported events of system controller faults and damage to the white power lead of the system controller were not confirmed.The system controller was not returned for evaluation and no log files or photos were submitted for review.Multiple requests were made to obtain additional information (including if the system controller faults resolved with the controller exchange, if the controller will be returned for evaluation, and the serial number of the controller); however, no response was received.The root cause of the reported events could not be conclusively determined through this analysis.Device history records could not be reviewed as the serial number of the product is unknown.Heartmate ii patient handbook under section 5 ¿alarms and troubleshooting¿ and heartmate ii instructions for use, under section 7 ¿alarms and troubleshooting¿ cover all alarms (visual and audible), including the controller fault alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate ii patient handbook section 6 "caring for the equipment" describes how to care for and clean all equipment, including the system controller power cables.Section 10, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate ii lvad, including inspecting the system controller power cables for damage.This section also informs the user to replace any equipment or system component that appears damaged or worn.Heartmate ii patient handbook section 2 "how your heart pump works" and heartmate ii instructions for use (ifu) section 2 "system operations" explain how maintain the backup system controller and how to replace the running system controller with the backup controller.Heartmate ii patient handbook and heartmate ii instructions for use (ifu) caution 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: HEARTMATE II SYSTEM CONTROLLER
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10580182
• Report Number: 2916596-2020-04573
• Device Sequence Number: 19635399
• Product Code: DSQ
• UDI-Device Identifier: 00813024013013
• UDI-Public: 00813024013013
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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 Model Number: 106762
• Device Catalogue Number: 10005080
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 127