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

Model Number 106762

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

Patient Problem Insufficient Information (4580)

Event Date 02/23/2024

Event Type  malfunction  

Event Description

It was reported that it looked like the batteries were drained and there was no power supplied.It was noted that there were some issues with the white and black cable connection.Log files were submitted for review.The log file displayed a possible power issue at the system controller power leads as the system controller recorded low rsoc voltages (0 volts) at the black and white power leads while tethered on batteries.The log file recorded no external power alarms beginning on 09:00 where the black and white power leads were disconnected from batteries; the system controller operated on the backup battery at that time.It appeared the batteries were reconnected around 09:01.Conversation between abbott and the physician was still ongoing but both parties suspected that the 14v battery drainage had eventually caused the patient death; the patient had routinely been using 14v batteries although staying home and had prior drainage experiences.Related manufacturer reference number: 2916596-2024-01266 (heartmate 3 lvas).

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, EU
• 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: 18868337
• MDR Text Key: 337336873
• Report Number: 2916596-2024-01265
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: 00813024011286
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/17/2021
• Device Model Number: 106762
• Device Lot Number: 6513572
• 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: 04/18/2018
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 65 KG