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

Model Number 106762

Device Problems Pumping Stopped (1503); Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/21/2024

Event Type  malfunction  

Event Description

It was reported that log file interrogation was requested after patient was status post code in the emergency room.It was stated that the alarm screen showed that the system controller clock needed to be reset, as the date was showing 01.01.01.An x-ray of the driveline was obtained, and the images were unremarkable.Technical services stated that the log file displayed "real time clock not set" alarms due to complete loss of power to the controller, causing the controller clock to reset due to depleted batteries in-use / possible user error on (b)(6) 2024 at roughly 8:33am.The controller operated on backup battery power / power save mode on 21feb2024 8:21 am - 8:33am where the controller recorded a pump stop / pump off event due to the complete loss of power.It could not be determined how long the pump was off.External power was restored to the controller at the black power cable lead with a fully charged battery.The log file recorded a string of "real time clock not set" alarms for the remainder of the log file.It was noted that the controller clock was set/synched with a heartmate touch (hmt).It was recommended to perform a controller self-test, and the site responded back that the self-test was normal.The site additionally stated that the controller and the hmt were still synced.Technical services noted that the controller was still showing a time/date stamp of (b)(6) 2001.Related manufacturer reference number: 2916596-2024-01336 (pump).

Manufacturer Narrative

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

• Brand Name: HEARTMATE II 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: 18923534
• MDR Text Key: 337897518
• Report Number: 2916596-2024-01337
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: 00813024011286
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/13/2023
• Device Model Number: 106762
• Device Lot Number: 7853324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2020
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 268 KG