MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number 106524US

Device Problems Pumping Stopped (1503); Electro-Static Discharge (2149); Communication or Transmission Problem (2896)

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

Event Date 03/28/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient was hospitalized.The patient's admission was strictly related to equipment and unknown left ventricular assist device (lvad) alarms.The patient stated that all the lights lit up on the controller and connect to power alarms occurred despite the patient being connected to batteries which had some charge.The patient stated that the pump running symbol was not illuminated at that time.This frightened the patient and they exchanged their own controller.The patient did not have another set of clips and was not near the mobile power unit (mpu) when they changed to the backup controller.All equipment appeared to be in good condition.Log file analysis captured several low voltage advisories and low voltage hazards as well as random power cable disconnects throughout the log while the patient was on battery power.The log also captured a brief pump stop on (b)(6) 2022 at 17:11 that lasted around 3 seconds and may have been due to an electrostatic discharge (esd) event.The pump restarted after the esd pump reset and about 7 seconds later the pump stopped again showing power a and b broken along with comm a and comm b faults.The controller appeared to have been exchanged about a minute later at (b)(6) 2022 at 17:12 when the driveline was disconnected.The event log following the controller exchange showed the driveline being disconnected on (b)(6) 2022 at 17:12 and captured no external power events on (b)(6) 2022 from 17:23-17:24 due to both power leads disconnected at the same time enabling the emergency backup battery in the controller to run the pump.Related manufacturer report number: #2916596-2022-02067.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of the patient¿s submitted log files confirmed two system stop events due to the driveline being disconnected, which the account attributed to the user error of the patient performing a controller exchange at home.The controller event log file from the original controller contained data from (b)(6) 2022 to (b)(6) 2022.The pump operated as intended at the set speed for the duration of patient support.On (b)(6) 2022 at 17:11:01 the driveline was disconnected, and the pump stopped.At 17:11:37 the driveline was reconnected, and the pump restarted.At 17:11:48 the driveline was again disconnected, and power was disconnected from the controller, which appeared to be associated with the reported controller exchange.The controller log files appeared to capture the pump operating as intended.Multiple requests for additional information were issued to the customer; however, no further information was provided.The patient remains ongoing on ventricular assist device (vad) support with no further issues reported.Review of the device history records showed no deviations from manufacturing or qa (quality assurance) specifications.The heartmate 3 lvas ifu, rev.C is currently available.Section 2 "system operations" (under "system controller warnings and cautions") states, "check the system controller driveline connector to confirm that the driveline is securely inserted in the socket.If the driveline disconnects from the system controller, the pump stops.If the driveline disconnects from the system controller, promptly reconnect it to resume pump operation." section 2 also contains a section titled "connecting the driveline to the system controller", which provides instructions on connecting/disconnecting the driveline to/from the system controller and making sure that it is fully and properly inserted into the system controller socket.Section 7 "alarms and troubleshooting" outlines all system controller alarms, including driveline disconnected alarms, as well as how to respond to each alarm condition.The heartmate 3 lvas patient handbook (rev.D) is also currently available.This handbook warns in several sections: "check the system controller driveline connector often to confirm that the driveline is securely inserted in the socket.If the driveline disconnects from the system controller, the pump will stop." and "the pump will stop if the driveline is disconnected from the system controller.If the driveline disconnects from the system controller, reconnect it right away to restart the pump.The pump cannot run without power." section 3 "powering the system" outlines the proper method for changing from the power module or mobile power unit to batteries and vice-versa under the sub-section titled ¿switching power sources¿.In addition, the patient handbook states, "call your hospital contact if you think that, for any reason, any portion of your equipment is not functioning as usual, is broken, or you are uncomfortable with the operation of the equipment." the patient handbook also contains a section on handling emergencies.Section 5 ¿alarms and troubleshooting¿ contains information regarding all system controller alarms, including the driveline disconnected hazard alarm, and the proper actions associated with them.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• 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: 14023169
• MDR Text Key: 289888470
• Report Number: 2916596-2022-02066
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• 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: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/15/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8210345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 133 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American