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

Model Number 106531US

Device Problem Material Deformation (2976)

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

Event Date 12/29/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion the reported event of damaged power cables was able to be confirmed.The heartmate 3 system controller (serial number: (b)(4)) was returned for analysis, and a log file was downloaded for review.A review of the submitted log files showed events spanning approximately 8 days ((b)(6) 2021 ¿ (b)(6)2021, (b)(6) 2022 per timestamp).Events captured on (b)(6) 2022 took place in the testing labs at abbott.Routine power cable disconnect alarms coincident with power source exchanges were active throughout the log file.The driveline was disconnected on (b)(6) 2021 at 10:56:11 and the controller was shut off at 10:56:46.There were no other notable alarms active in the log file.Pump operation was not affected.The controller underwent preliminary and functional testing and did not pass.The controller was able to operate a mock loop with no alarms active.The controller was able to function as intended; however, the controller did not pass continuity nor insulation testing.There was no damage found on the wires; however, the wires showed significantly increased resistance.The root cause of the reported event was unable to be conclusively determined through this investigation.Heartmate iii instructions for use, rev.C, section 2 entitled ¿system operations¿ and heartmate iii patient handbook, rev.C, section 2 entitled ¿how your heart pump works¿ states ¿do not twist, kink, or sharply bend the driveline, system controller power cables, power module patient cable, or mobile power unit patient cable, which may cause damage to the wires inside, even if external damage is not visible.¿ heartmate iii instructions for use, rev.C, section 8 entitled ¿equipment storage and care¿ and heartmate iii patient handbook, rev.C, section 6 entitled ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use.The patient handbook cautions the users 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.The device history records were reviewed for the system controller (serial number: (b)(4)) and was found to pass all manufacturing and qa specifications before being shipped to the customer.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient's primary controller was exchanged due to damage at the black power cord.There was a tear through the sheath that was down to the wiring.The old controller was exchanged without issue.

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSISST) 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: 13934255
• MDR Text Key: 288323952
• Report Number: 2916596-2022-01564
• 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: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2022
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7337001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2019
• 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: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White