MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER; VENTRICULAR (ASSIST) BYPASS

Model Number 106531INT

Device Problems Disconnection (1171); Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Pumping Stopped (1503)

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

Event Date 07/18/2022

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the system controller (b)(4) was exchanged for system controller (b)(4) for an unknown reason.While (b)(4) was in use, controller internal fault, pump off, driveline disconnected, and low flow alarms were active.The patient was admitted to the hospital due to loss of consciousness when the pump stop alarm was active.(b)(4) was exchanged for (b)(4) due to the active alarms and the alarms resolved.As of (b)(6) 2022, the patient was intubated and was under examination.Mfr # for (b)(4): 2916596-2022-12398.Mfr # for (b)(4): 2916596-2022-12396.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a controller internal fault alarm was confirmed via the log files and reproduced.A review of the log files spanned approximately 4 days (04oct21, 28jan22, 18jul22, and 20jul22 per time stamp).Data prior to 18jul22 is not relevant to this investigation.On 18jul22 at 12:05 while the motor speed remained at 0 rpm, the driveline disconnect and controller internal fault alarm activated due to an ocp_b_broken fault.The controller was attempted to be silenced and reset but the alarms persisted through the remainder of the log file.No other notable alarms.The system controller, serial number (b)(6), returned with a controller fault due to an open fuse b.Further troubleshooting was performed and a small scorch mark was found in the bulkhead connector pin socket.Fuse b was replaced to continue with testing.The controller was then functionally tested and found to operate as intended during analysis.The controller was able to support pump function for an extended period of time.The data captured in the log file, the scorch mark on the driveline connector, and the damaged fuse indicate that the root cause of the reported event was the driveline being incorrectly inserted into the controller by 180 degrees.Device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The patient handbook and instructions for use (ifu) also 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 3 instructions for use section 7-¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot controller fault alarms.The heartmate 3 patient handbook addresses the proper steps for connecting the driveline to the system controller.Heartmate 3 instructions for use section 8-¿equipment storage and care¿ and heartmate 3 patient handbook section 6-¿caring for the equipment¿ explain how to properly take care and maintain the integrity of the system controller housing, connectors, and cables.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 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: 15073873
• MDR Text Key: 303059885
• Report Number: 2916596-2022-12397
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Model Number: 106531INT
• Device Lot Number: 6523414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2018
• 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: 69 YR