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

Model Number 106531US

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

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

Event Date 12/17/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient reported having alarms on the system controller while they were connected to the mobile power unit (mpu).The patient reported that there were no lights on the mpu.The outlet was switched, and the issue continued while connected to the other outlet.The patient was changed back to battery power.It was noted that during the time when the patient was off of the mpu, the green power light went off.The customer stated there was something wrong with the mpu and questioned if it could be caused by internal wire damage.It was noted that the patient had a locking ac power cord on the mpu.It was also reported that there were no accidental pulls of the ac cord nor any incidents where the ac cord came out of the outlet.Log files were submitted for review and captured power cable disconnect/no external power alarms on (b)(6) 2023 at 21:41 and 22:45.These alarms were caused by power to the mpu being briefly interrupted.There were no interruptions in pump support during these events as the controller¿s backup battery functioned as intended.The alarms resolved upon reconnection to battery power.There were no other notable alarm conditions or parameter changes seen in the log files.The patient was issued a new mpu.It was also reported that the patient was issued a new system controller as the bend relief was damaged.Related manufacturer reference number for the heartmate mobile power unit: (b)(4).

Manufacturer Narrative

Manufacturer¿s investigation conclusion: the reported event of a system controller exchange due to a damaged strain relief on the heartmate 3 system controller was not confirmed.The heartmate 3 system controller (serial number (b)(6)) was not returned for analysis.Additionally, there were no photos or other documents submitted that would confirm the reported event.The submitted controller event log file contained relevant data spanning approximately 7.5 days (11dec2023 ¿ 18dec2023), per the timestamp).Pump operation was not affected throughout the log file.The log file captured an atypical power cable disconnect alarm active while connected to battery power on 12dec2023 at 14:55:27 due to the rsoc voltage in the black power cable dropping to approximately 0 volts without any routine voltage depletion or power source changes.Multiple attempts were made to obtain additional information about the reported event such as if the serial number of the controller that was replaced due to the bed relief could be provided, and if any product will be returning for analysis; however, no response was given.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 the heartmate 3 system controller (serial#: (b)(6)) was manufactured in accordance with manufacturing and qa specifications.Heartmate 3 patient handbook, under section 5 ¿alarms and troubleshooting¿ and heartmate 3 instructions for use (ifu) under section 7 ¿alarms and troubleshooting¿ cover all alarms (visual and audible), including the low voltage advisory, power cable disconnect and low voltage hazard alarm conditions, no external power, and the actions to take if the alarms cannot be resolved.Furthermore, the subsection ¿what not to do: driveline and cables¿ informs the user to check the system controller power cables for twisting, kinking, or bending which could cause damage to the wires inside.This section informs the user not to ¿twist, kink, or sharply bend the system controller power cables¿ and states ¿if the driveline or cables become twisted, kinked, or bent, carefully unravel and straighten¿.Heartmate 3 patient handbook section 6 "caring for the equipment" and heartmate 3 instructions for use (ifu) section 8 ¿equipment storage and care¿ describe how to care for and clean all equipment, including the system controller.Heartmate 3 patient handbook section 10 and heartmate 3 instructions for use (ifu) section f, both entitled ¿safety checklists¿, provide checklists to assist the patient in performing routine maintenance of heartmate 3 lvad, including inspecting the system controller.This section also informs the user to replace any equipment or system component that appears damaged or worn.Heartmate 3 patient handbook cautions 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 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18510847
• MDR Text Key: 333487855
• Report Number: 2916596-2023-08866
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/20/2024
• Device Model Number: 106531US
• Device Lot Number: 8491222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2022
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic