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

Model Number 106762

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

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

Event Date 12/27/2021

Event Type  malfunction  

Manufacturer Narrative

The serial number of the controller has been requested but not yet provided.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is completed.

Event Description

It was reported that a broken black power connector that was unable to lock into a power source was noted.Several low power hazard events that occurred with the white power lead disconnected from power were noted in log file analysis, indicating that the connection at the black power lead had been compromised.Given the damage and older software version of the controller, it was recommended that the pocket controller be replaced.

Manufacturer Narrative

Manufacturer's investigation conclusion.The reported events of atypical power cable disconnect and no external power alarms were able to be confirmed via review of the log file; however, the event of a broken power cable connector was unable to be confirmed.The heartmate ii system controller was not returned for analysis; however, a log file was submitted for review.A review of the submitted log files showed events spanning approximately 8 days (b)(6) 2021 ¿ (b)(6) 2021 per timestamp).The controller recorded intermittent power cable disconnect alarms that were associated with a power source exchange due to power cable faults, occurring on both cables.The power cable disconnect alarm activated with these events as well.All of the atypical power cable disconnects occurred during power source exchanges.These atypical alarms occurred at the time stamps of (b)(6) 2021 from 09:30:06 ¿ 17:04:26, (b)(6) 2021 from 11:22:39 ¿ 17:40:14, intermittently on (b)(6) 2021 from 20:55:35 ¿ (b)(6) 2021 at 16:59:06, and intermittently on (b)(6) 2021 from 09:46:09 ¿ 22:50:58.No external power alarms coincident with dual disconnections of the power cables were intermittently active on (b)(6) 2021 from 09:46:11 ¿ 21:03:55, and intermittently on (b)(6) 2021 from 19:28:00 ¿ 23:44:56.The backup battery was able to provide power to the system during the alarms.The alarms cleared once the power cables were reconnected to power.There were no other notable alarms active in the log file.Multiple good faith effort attempts were made asking if the low power alarms were resolved, for the serial number of the controller, if it was exchanged, and if it will be returning; however, no response was received.The root cause of the reported events were unable to be conclusively determined through this investigation.Heartmate ii instructions for use (rev.C) section 7 entitled ¿alarms and troubleshooting¿ and heartmate ii patient handbook (rev.C) section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms, including no external power and power cable disconnect alarms.Heartmate ii instructions for use (rev.C) section 8 entitled ¿equipment storage and care¿ and heartmate ii 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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II 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: 13308649
• MDR Text Key: 284513596
• Report Number: 2916596-2022-00290
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: 813024011286
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106762
• Was Device Available for Evaluation?: No
• 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?: Device Not Returned to Manufacturer
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 74 KG