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

Model Number 106531US

Device Problems Device Alarm System (1012); Electrical /Electronic Property Problem (1198); Communication or Transmission Problem (2896)

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

Event Date 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the system controller initiated a controller fault alarm during the implant procedure.It functioned appropriately during pump prep, and was up on the sterile field at the time of the alarm.The alarm could not be silenced and communication was lost to the heartmate touch monitor.In order to troubleshoot this issue, the controller was exchanged off the field, with the backup controller being utilized as patient's primary.The malfunctioning controller was sent back for evaluation.It was later reported on (b)(6) 2022 that the controller exchange resolved all alarms and that the patient did not experience any adverse effects.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a controller fault alarm and compromised communication between the system controller and the external monitor was confirmed and reproduced during analysis.The returned system controller was connected to a test power module patient cable, test power module, and test system monitor.The system monitor displayed ¿not connected¿ message and the controller screen displayed ¿call hospital contact/controller fault¿ and a yellow wrench symbol/alarm was active.Connected a test hm3 pump and the pump initiated operation with the controller fault alarm being active.During further troubleshooting, brief communication was established and the log files were able to be retrieved.The data contained in the event log file revealed that on (b)(6), 2022 the system controller was connected to a power module with a pump not connected when an intermittent controller internal fault associated with a timebase fault alarm became active.The periodic log file did not contain any events.Further evaluation isolated the problem to the microcontroller circuit on the printed circuit board (pcb); however, the specific root cause was not able to be determined.The device history records were reviewed and the records revealed the system controller was manufactured in accordance with mfg and qa specifications.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: 14575168
• MDR Text Key: 293528676
• Report Number: 2916596-2022-11076
• 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,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 8142445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2021
• 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: 33 YR
• Patient Sex: Female
• Patient Weight: 76 KG