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 09/11/2023

Event Type  malfunction  

Event Description

It was reported that the patient had power cable disconnect alarms and damage to the black power lead bend relief.The controller was exchanged, resolving the alarms.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of unexpected power cable disconnect alarm was confirmed via log file review; however, the reported event of damaged bend relief on the black power cable could not be confirmed.The log file captured unexpected power cable disconnect alarm events relating to a loss of the battery fuel gauge voltage signal.The alarm was consistently associated with the black power cable.The analysis could not determine a correlation between the power cable disconnect alarm and the reported damaged black power cable.Additional information communicated that the system controller was exchanged, which resolved the alarm issue.System controller will not be returned for an evaluation.A root cause of the unexpected power cable disconnect alarm and damaged black power cable could not be determined during the evaluation.Device history record indicated the device was manufactured in accordance to mfg and qa specifications.Heartmate 3 patient handbook cautions the users to ¿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.Your hospital contact can check the equipment and order replacements, if needed.Do not try to repair anything yourself.¿ under section 10 ¿safety checklists¿, instructs users to ¿check all electrical connections between the system controller and power cables, the power cables and the mobile power unit patient cable, and the mobile power unit and ac electrical outlet.¿ under section 5 ¿alarms and troubleshooting¿, all alarm conditions are addressed.This includes ¿connect power¿ alarms.Low voltage advisory alarm.1.Promptly connect to a working or different power source (mobile power unit or two fully-charged heartmate 14 volt lithium-ion batteries).2.If alarm persists, call your hospital contact immediately.For more information, see page 228.No external power alarm.1.Immediately connect the system controller power cables to a working power source (functioning mobile power unit or two fully-charged heartmate 14 volt lithium-ion batteries).2.Call your hospital contact immediately if connecting to power does not resolve the alarm.Power cable disconnect alarm.1.Promptly connect the disconnected power cable to a working power source (mobile power unit or two fully-charged heartmate batteries).2.Call your hospital contact if reconnecting the power cable does not resolve the alarm.Under section 3 ¿powering the system¿, explains mobile power unit usage.Under section 2, ¿how your heart pump works¿, covers replacing the running system controller with a backup controller.Also, important warning information associated with the system controller exchange.Heartmate 3 instructions for use under section f, safety checklists, replace any equipment or system component that appears damaged or worn.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: 17867984
• MDR Text Key: 324881624
• Report Number: 2916596-2023-06871
• 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
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/25/2023
• Device Model Number: 106531US
• Device Lot Number: 7726702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2020
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American