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

Model Number 106531US

Device Problem Alarm Not Visible (1022)

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

Event Date 02/26/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient called on (b)(6) 2023 at 6:00pm to report sounds of low flow alarms.The controller did not display an active alarm.It was confirmed that the pump running symbol was lit and the controller passed a self-test.The patient's daughter looked at the controller and observed a flow of 3.1 liters per minute (lpm) and pulsatility index (pi) of 12.8.The alarm condition resolved when the patient sat up.Interrogation in the clinic on (b)(6) 2023 did not show any alarms.Log file review found low flow events on (b)(6) 2023 and (b)(6) 2023 in addition to several low flow flags which did not persist long enough to trigger a low flow alarm.It was later reported that when the patient called the ventricular assist device (vad) team on (b)(6) 2023, it was to report alarms but necessarily low flow alarms.The display screen was not flashing low flow at the time of the alarm as explained by the patient who knew to check the parameters.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of an unknown alarm beeping from the controller while the display was not showing any alarms was not confirmed.The submitted controller event log file contained approximately 5 days of data (26feb2023 ¿ 03mar2023 per the timestamp).The log file did not capture any atypical alarms on 02mar2023; it was noted that the controller was connected to the mobile power unit (mpu) throughout the events captured on 02mar2023.The pump maintained a speed above the low speed limit throughout the log file.Additional information provided stated that the heartmate 3 system controller (serial number: (b)(6) ) was not exchanged and that the controller was not displaying low flow alarms when the reported unknown alarms occurred.Multiple requests for additional information were made to determine if the cause of the unknown alarm was determined, if any additional alarms activated, and if there were any issues observed with the patient cable on the mpu; however, no response was received.The root cause of the reported event could not be conclusively determined through this analysis.The device history records were reviewed and the records revealed that the heartmate 3 system controller, serial number (b)(6), was manufactured in accordance with manufacturing and qa specifications.The heartmate 3 system controller was shipped to the customer on 06apr2022.Heartmate 3 instructions for use (rev.C) section 7, entitled ¿alarms and troubleshooting¿, and heartmate 3 patient handbook (rev.D) section 5, entitled ¿alarms and troubleshooting¿ covers all alarms (visual and audible), and the actions to take if the alarm cannot be resolved.Heartmate 3 instructions for use (rev.C) section 8 entitled ¿equipment storage and care¿ and heartmate 3 patient handbook (rev.D) section 6 entitled ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use.The heartmate 3 patient handbook (rev.D) 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: 16584528
• MDR Text Key: 312026527
• Report Number: 2916596-2023-01648
• 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: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 8363679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2022
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American