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

Model Number 106531US

Device Problem Low Audible Alarm (1016)

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

Event Date 05/03/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient had low alarm volume during a self-test.Additionally, the tone would intermittently cut out or be muted.While the patient was in the clinic, their controller was exchanged for their backup controller.

Manufacturer Narrative

Manufacturer's investigation conclusion the reported event of a low volume alarm was able to be confirmed.The heartmate 3 system controller (serial number: (b)(6)) was returned for analysis, and a log file was downloaded for review.A review of the log files showed events spanning approximately 6 days ((b)(6) 2022, (b)(6) 2000 per timestamp).Events captured on (b)(6) 2022 took place in the testing labs at abbott.Events captured on (b)(6) 2000 took place when the clock was not set; therefore, the exact days and times of the events were unable to be accurately recorded.The driveline was disconnected on (b)(6) 2022 at 13:12:13 and the controller was shut off at 13:12:54.There were no notable alarms active in the log file pertaining to the reported event.Pump operation was not affected.The system controller underwent preliminary and functional testing and passed.The system controller was returned with debris inside the buzzer¿s opening which may have reduced the volume of the alarm causing a muffled or muted tone.The debris was removed prior to testing.The system controller was able to operate a mock loop with no alarms active and functioned as intended.Upon further investigation, a decibel (db) reader was used to measure the alarms on the controller.Each buzzer was measured to be above the expected 85db.The buzzers were measured to be 92db; however, one buzzer was measured to be lower at 86db.The controller was opened to inspect the condition of the wires leading to the buzzers and were found to be in unremarkable condition.No further testing was conducted.Additional information provided on (b)(6) 2022 stated that exchanging the controller resolved the issue.The root cause of the reported event was unable to be conclusively determined through this investigation.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.Heartmate iii instructions for use, 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, and the actions to take if the alarms cannot be resolved.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: hsc-084093) 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.

• 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: 14456292
• MDR Text Key: 292204976
• Report Number: 2916596-2022-10930
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

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: Health Professional
• Device Expiration Date: 11/26/2022
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7313839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2019
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 122 KG