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

Model Number 106762

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of atypical power cable disconnect alarms was confirmed via analysis of the log file downloaded from the returned system controller (serial number: (b)(4); however, the alarms were not reproduced during testing of the returned controller.The downloaded log file contained approximately 4 days of data (b)(6) 2022 per the timestamp).The log file captured power cable disconnect alarms that were not associated with true power cable disconnections on (b)(6) 2022 from 09:33:30 to 09:45:18 due to the relative state of charge (rsoc) dropping to approximately 0 v.The atypical alarms occurred while connected to 14v batteries and occurred on the white power lead.No other notable alarms were observed in the log file.The atypical alarms did not affect the controller¿s ability to operate the pump at the set speed.The returned system controller passed functional testing and evaluation of the power cables did not reveal any issues.The controller successfully operated in a mock circulatory loop for an extended period of time without any issues or atypical alarms being produced, including when the controller power cables were manipulated by hand.The root cause of the reported event could not be conclusively determined through this analysis.The device history records were reviewed and the records revealed that the heartmate ii system controller, serial number (b)(4), was manufactured in accordance with manufacturing and qa specifications.The system controller was shipped to the customer on (b)(6) 2017.Heartmate ii instructions for use section 7 ¿ ¿alarms and troubleshooting¿ and heartmate ii patient handbook section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms (visual and audible), including power cable disconnect alarms, and the actions to take if the issue does not resolve.The patient handbook and the instructions for use caution the user 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.

Event Description

It was reported that the patient experienced power cable disconnect alarms.It appeared that the black power lead had an issue.The system controller was replaced and the alarms resolved.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• Type of Device: 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: 15084960
• MDR Text Key: 304721961
• Report Number: 2916596-2022-12358
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: 00813024011286
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Device Lot Number: 5826638
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 73 KG