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

Model Number 106762

Device Problems Disconnection (1171); Improper or Incorrect Procedure or Method (2017); Complete Loss of Power (4015)

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

Event Date 02/16/2024

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 primary system controller appeared to have been without power for 6 minutes on (b)(6) 2024.The patient presented to an outside hospital emergency room at 1830 on (b)(6) 2024, and the site stated that the outside hospital attempted to perform a controller exchange to the patient's backup.Log file review was requested and contained alarms associated with a loss of external power event.The patient appeared to have been utilizing battery power on (b)(6) 2024 and depleted both batteries.During the event, the controller did switch appropriately to the backup battery (bb).While in bb mode the log file indicated the driveline was briefly disconnected and reconnected causing the pump stop events.The event alarms appeared to resolve once external power was reconnected.The pump then resumed normal operation.Technical services noted that the patient did not appear to have been swapped over to the backup controller as that file did not show any pump connection since 2017.It was also noted that the patient appeared to be sleeping on battery power which was not recommended.According to the patient, the no external power (nep) event was due to their batteries being drained.It was also noted by the patient that the reason for the driveline being disconnected and reconnected was because their batteries were drained.The site noted that the cause of the nep event and the disconnection of the driveline were all hear-say.The patient did not have any adverse consequences/symptoms during the pump stop.The site noted that they were observed at the hospital and the patient was fine.It was unknown why the controller was being changed.Related manufacturer reference number: 2916596-2024-01151 (pump).

• 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: 18886423
• MDR Text Key: 337446790
• Report Number: 2916596-2024-01188
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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