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

Model Number 106531US

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 03/01/2022

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 was feeling "shocks" from the controller while they were connected to the mobile power unit (mpu).They noted they occurred at and around areas where the paint was chipped and metal was exposed.Log files did not reveal any unusual events.The patient's controller was exchanged which did not resolve the shocks.Related mfr number: 2916596-2022-01508.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the returned system controller (serial number (b)(6)) delivering ¿shocks¿ was not confirmed.The provided log file from this controller, as well as a log file extracted from the controller during testing, were reviewed, collectively containing data spanning approximately 2 days ((b)(6) 2022 ¿ (b)(6) 2022 per timestamp).The pump maintained speeds equal to the low speed limit throughout the data, as the fixed speed and low speed limit were set to the same value.No atypical events were observed throughout the data.The returned system controller was functionally tested and was found to perform as intended.Electrical shocks from the controller were unable to be reproduced throughout all testing, as no atypical sensations were felt nor observed around the controller¿s exposed metal throughout all testing.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for system controller, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The heartmate 3 patient handbook (rev.C, section 2 ¿how your heart pump works,¿ section 3 ¿powering the system,¿ section 4 ¿living with the heartmate 3,¿ and section 6 ¿caring for the equipment¿) instructs the user on how to properly maintain their equipment, including the system controller and the mpu, in such ways that would avoid the user feeling an electrical shock.The heartmate 3 patient handbook (rev.C, section 10 ¿safety checklists¿) instructs users to regularly inspect their equipment, including their system controller, and to replace any equipment that appears damaged or worn.The heartmate 3 patient handbook (rev.C, section titled "emergency contact list") cautions 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.No further information was provided.The manufacturer is closing the file on this event.

• 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: 13874438
• MDR Text Key: 289494750
• Report Number: 2916596-2022-01509
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/05/2022
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7363280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 03/25/2022
• Supplement Dates FDA Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2019
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White