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

Model Number 106531US

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a controller clock corrupt alarm was confirmed with the submitted log file.The periodic log file captured a controller clock corrupt alarm event related to the date being set between january 3, 2000 and january 11, 2000.The captured year of 2000 suggests the system controller may have experienced a total loss of power, which would have defaulted the date to january 1, 2000.The date/time appeared to have been synced on march 19, 2022 and the alarm cleared.The log file was retrieved from system controller (serial # (b)(4)).The system controller is not expected to be returned for an evaluation.All available information for conducting this investigation was collected and no additional follow-up attempts will be performed.To date, the system controller associated with the event was unavailable for an evaluation.The complaint file will close accordingly and will be reopened if pertinent information is received.Device history record indicated the device was manufactured in accordance to manufacturing and quality assurance specifications.System controller (serial # (b)(4)) was shipped to the customer on 21feb2020.Heartmate 3 patient handbook rev b, 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 5 ¿alarms and troubleshooting¿ under this section, all alarm conditions are addressed including system controller fault alarms indicating to ¿call your hospital contact as soon as possible for diagnosis and instructions.¿ heartmate 3 instructions for use (ifu) rev c, ¿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.

Event Description

It was reported that the patient had not been charging their backup system controller backup battery as instructed, so after the patient switched to their backup controller, the controller clock was not set.It was reset in clinic on (b)(6) 2022.Related manufacturer report number: 2916596-2022-01819.

• 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: 14289493
• MDR Text Key: 290960542
• Report Number: 2916596-2022-10767
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/03/2022
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7409675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2019
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White