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

Model Number 106762

Device Problems Disconnection (1171); Mechanical Problem (1384); Device Difficult to Setup or Prepare (1487); Separation Failure (2547); Electrical Power Problem (2925); Material Deformation (2976); Complete Loss of Power (4015)

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

Event Date 10/03/2021

Event Type  malfunction  

Manufacturer Narrative

The previous driveline tears are reported in mfr report #2916596-2021-05974.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

Related manufacturer report number: 2916596-2021-05877.It was reported that the patient experienced low voltage alarms and connect to power alarms on batteries and patient cable due to potential issues with the system controller white power lead.There were no issues with the system controller black power lead.Battery clips were replaced with new ones and the same issue occurred.It was requested to replace the patient's system controller with a new one however, it was reported that the driveline distal end percutaneous lead appears to be stuck in the system controller.It did not easily release/disengage when enabling the system controller red percutaneous lead release button.In addition, the patient had a clamshell repair with cosmetic tears in the silastic jacket wrapped with rescue/fusion tape.It was thought that the patient had a short in the white power lead of their system controller and it was intermittently losing the ability to send power to the system.The system controller was not able to be exchanged as the driveline was unable to be disconnected from the system controller.Submitted log files noted multiple strings of power cable disconnects on the system controller white power lead.There was a cosmetic driveline repair on (b)(6) 2021.The driveline was repaired approximately 9 inches from the exit site.There was green gunk noted on the original percutaneous lead metal connector and within the original system controller.The patient's system controller was replaced with a new one.The patient was tethered on grounded patient cable without issue.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of power cable disconnect alarms and difficulty disconnecting the driveline were confirmed and reproduced.A review of the log files spanned approximately 4 days ((b)(6) 2021 per time stamp).From (b)(6) 21 at 07:52 to the end of the log file while connected to batteries and the power module, the power cable disconnect alarm activated due to rsoc voltages fluctuating outside the expected voltage range on the white power cable.These events coincided with a few atypical low voltage advisory alarms as well.The alarms did not affect the controller's ability to operate the pump at the set speed.No other notable alarms were active in the log file.The heartmate ii system controller was functionally tested and the power cable disconnect alarm was reproduced.The controller returned with cuts in both power cables and a damaged white strain relief.The cable jackets and shielding were stripped back revealing a severed brown battery gauge wire approximately one inch from the white power cable strain relief.It was difficult to press the driveline disconnect button due to the extensive amount of fluid ingress found inside the bulkhead assembly and housing of the controller.The controller was able to support pump function for an extended period of time.The root cause for the reported power cable disconnect alarm was due to a severed wire in the white power cable.The root cause for the reported event of difficulty disconnecting the driveline was due to fluid ingress in the bulkhead assembly.Device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The patient handbook cautions the 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.Heartmate ii instructions for use section 7-¿alarms and troubleshooting¿ and heartmate ii patient handbook section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot power cable disconnect and low voltage alarms.Heartmate ii instructions for use section 8-¿equipment storage and care¿ and heartmate ii patient handbook section 6-¿caring for the equipment¿ explain how to properly maintain the integrity of the system controller.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSISST) 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: 12713018
• MDR Text Key: 278875301
• Report Number: 2916596-2021-05955
• 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,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2020
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Device Lot Number: 6050698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2017
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 115 KG