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

Model Number 106531INT

Device Problems No Display/Image (1183); Communication or Transmission Problem (2896); Electrical Power Problem (2925)

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

Event Date 02/22/2022

Event Type  malfunction  

Event Description

It was reported that the patient's device alarmed for low voltages.The battery clips and mobile power unit were exchanged, but the alarms reoccurred and the screen disappeared from time to time.The controller was exchanged which resolved the alarms.

Manufacturer Narrative

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

Event Description

The screen of the system monitor disappeared from time to time.

Manufacturer Narrative

Section d6a: date of implant inadvertently reported in initial report and is not applicable for this device manufacturer's investigation conclusion: the reported events of the system controller having intermittent communication with the system monitor and atypical low voltage alarms were confirmed.Upon return of the heartmate 3 system controller (serial number: (b)(6)), a log file containing approximately 3 days of data (20feb2022 to 23feb2022 per time stamp) was downloaded for review.Intermittently throughout the log file, atypical low power hazard alarms were observed while the controller was connected to the mobile power unit.These alarms activated due to the rsoc briefly falling below the alarm threshold.The atypical alarms cleared within a few seconds of activation each time and did not impact the ability of the pump to operate at the set speed.No other atypical events were observed throughout the data.Visual inspection of the returned controller revealed kinks in both the black and white power cables.During functional testing, it was noted that both power cables had increased electrical resistance values.Further testing indicated that the affected inner wires included one wire within the white cable which pertains to the communication between the controller and system monitor.Manipulation of the cables in the area of the kinks caused large variations in resistance; however, interruptions in communication such as those observed in the submitted video were unable to be reproduced.The controller operated the mock loop as intended throughout all testing.The root cause of the reported communication interruptions was determined to be fatigue of the communication wire within the white power cable.The observed wire fatigue may have also caused the observed low voltage alarms to intermittently occur; however, the root cause of these alarms could not be conclusively determined, as they were unable to be reproduced during evaluation of the returned controller.Review of the device history record for the system controller, serial number (b)(6), showed that the device was manufactured in accordance with manufacturing and qa specifications.The heartmate 3 patient handbook section 5 "alarms and troubleshooting¿, addresses how to properly interpret and troubleshoot all system alarms including low voltage advisory and power cable disconnect alarms.The heartmate 3 patient handbook section 6 "equipment maintenance", describes how to care for and clean all equipment, including the system controller and its power cables.The heartmate 3 patient handbook section 10 entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate 3 lvad, including inspecting the system controller power cables for damage.The patient handbook cautions 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.

• 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: 13737222
• MDR Text Key: 289322377
• Report Number: 2916596-2022-01260
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2021
• Device Model Number: 106531INT
• Device Lot Number: 6681018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2018
• 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