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

Model Number 106531US

Device Problems Disconnection (1171); Mechanical Problem (1384)

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

Event Date 02/27/2024

Event Type  malfunction  

Event Description

It was reported that during a patient visit the system controller was noted to have a driveline power fault, as well as dust/debris in the modular cable connection.The modular cable and controller were exchanged and no further alarms were noted.Log files were submitted for review and contained the onset of driveline power a faults on (b)(6)2024.There were also 2 separate sets of alarms associated with driveline disconnects on (b)(6)2024.It was noted that following the disconnects the driveline fault appeared to have persisted.The driveline disconnects were reportedly not related to troubleshooting, and it was unknown if the modular cable had any trauma, though no visible damage was noted.Related manufacturer's reference number for the pump: 2916596-2024-01494 related manufacturer's reference number for the modular cable: 2916596-2024-01496.

Manufacturer Narrative

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

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSIST) DEVICE
• 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: 18963528
• MDR Text Key: 339028417
• Report Number: 2916596-2024-01495
• 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
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106531US
• Device Lot Number: 8322711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/16/2022
• 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: 32 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American