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

Model Number 106531US

Device Problems Disconnection (1171); Electrical Power Problem (2925); Material Deformation (2976)

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

Event Date 04/19/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient performed an at-home controller exchange on (b)(6) 2022 due to frequent power cable disconnect and low voltage alarms.Log file analysis confirmed the power cable disconnect and low voltage alarms beginning on (b)(6) 2022; these were not associated with any power source changes.These events continued for the remainder of the event log until the controller was exchanged (b)(6) 2022.The patient reported that all gold connections were clean and that the batteries were charged.On (b)(6) 2022, the patient exchanged received a new back up controller at the clinic.The patient¿s batteries and battery clips were inspected and were in unremarkable condition.The white power cable of the system controller was noted to have broken pieces on the bend relief and a slight bulge.The controller exchange resolved the event.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of atypical power cable disconnect alarms was able to be confirmed via review of the log file; however, was unable to be confirmed during product testing.The heartmate 3 system controller (serial number: (b)(6) ) was returned for analysis, and a log file was submitted for review and another was downloaded for review.A review of the submitted log files showed overlapping events spanning approximately 14 days ((b)(6) 2022 per timestamp).Events captured on (b)(6) 2022 took place in the testing labs at abbott.Atypical power cable disconnect alarms coincident with rsoc invalid faults occurred intermittently on (b)(6) 2022 at 20:17:18 ¿ (b)(6) 2022 at 09:19:15.The alarms occurred on the white power cable while connected to battery power.The alarms cleared shortly after activating.The driveline was disconnected on (b)(6) 2022 at 09:19:59 and the controller was shut off at 09:22:26.There were no other notable alarms active in the log file.Pump operation was not affected while the driveline was connected.The system controller underwent preliminary and functional testing and passed.The system controller was able to operate a mock loop with no alarms active.The system controller was able to function as intended.The root cause of the reported event was unable to be conclusively determined through this investigation.Heartmate iii instructions for use (ifu) rev.C section 7 entitled ¿alarms and troubleshooting¿ and heartmate iii patient handbook rev.C section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms including power cable disconnect alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate iii ifu 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)(6) ) and was found to pass all manufacturing and qa specifications before being shipped to the customer on 11jun2020.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: 14275122
• MDR Text Key: 290679429
• Report Number: 2916596-2022-10626
• 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: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/03/2022
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7513460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2019
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 133 KG
• Patient Ethnicity: Non Hispanic