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

Model Number 106531US

Device Problems Premature Discharge of Battery (1057); Corroded (1131); Mechanical Problem (1384); Material Deformation (2976)

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

Event Date 07/19/2022

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 concerned about their white battery lead as there were two small cuts with green oxidation that was noticed on the morning of (b)(6) 2022.The patient denied alarms but said the white battery was draining much faster.Their controller was exchanged.The log files did not contain any unusual events.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of fluid ingress and damaged power cables were able to be confirmed; however, the event of premature battery depletion were unable to be confirmed.The heartmate 3 system controller (serial number: (b)(6) was not returned for analysis; however, a log file was submitted for review.A review of the submitted log files showed events spanning approximately 2 days ((b)(6) 2022 per timestamp).There were no notable alarms active in the log file.Pump operation was not affected.The battery charges were not shown to be depleting prematurely.Photos submitted of the reported damage to the power cables show two cuts in the power cable with fluid ingress.The root cause of the reported events was unable to be conclusively determined through this investigation.The device history records were reviewed for the system controller (serial number: (b)(6) and was found to pass all manufacturing and qa specifications before being shipped to the customer.Heartmate iii instructions for use section 8 entitled ¿equipment storage and care¿ and heartmate iii patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use including how to ensure that the controllers and equipment do not get wet.Heartmate iii patient handbook section 2 ¿how your heart pump works¿) tells users that two fully charged 14-volt batteries are expected to power the system for approximately 10-12 hours, which can vary depending on activity level.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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15085807
• MDR Text Key: 304513362
• Report Number: 2916596-2022-12428
• 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,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/25/2023
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7711982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American