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

Model Number 106762

Device Problems Communication or Transmission Problem (2896); Material Deformation (2976)

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

Event Date 05/16/2022

Event Type  malfunction  

Event Description

It was reported that when the patient was placed on the system monitor, the monitor showed that data was not being transferred.It was noted that the patient's white power lead had compromised integrity.The controller was exchanged to the backup controller which resolved the issue and allowed the data transfer to the system monitor.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the system controller not communicating with the system monitor was able to be confirmed.The heartmate ii system controller (serial number: pcx-17829) was returned for analysis, and a log file was downloaded for review.A review of the submitted log files showed events spanning approximately 6 days (10may2022 ¿ 16may2022 per timestamp).There were no notable alarms active in the log file.All alarm conditions were a result of routine power cable disconnect alarms occurring during power source exchanges.The driveline was disconnected on (b)(6) 2022 at 07:52:48 and the controller was shut off at 07:52:55.There were no other notable alarms active in the log file.Pump operation was not affected while the driveline was connected.The system controller did not communicate with the system monitor upon return.The power cables underwent continuity testing and did not pass as the wires showed severely increased resistances; however, the power cables did pass insulation testing.The power cables were replaced with test cables and the issue was resolved.The system controller underwent preliminary and functional testing following the repair and passed.The system controller was able to operate a mock loop with no alarms active and functioned as intended.The power cables were cut open to inspect the condition of the underlying layers and fluid ingress was found.There was no physical damage found on the wires; however, the fluid ingress and wire fatigue may have contributed to the reported event.No further testing was conducted.The root cause of the reported event was unable to be conclusively determined through this investigation.The device history records were reviewed for the system controller (serial number: pcx-17829) and was found to pass all manufacturing and quality assurance specifications before being shipped to the customer on (b)(6) 2019.Heartmate ii instructions for use (ifu) section 8 entitled ¿equipment storage and care¿ and heartmate ii 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.Section 2 entitled ¿system operations¿ and heartmate ii patient handbook section 2 entitled ¿how your heart pump works¿ states ¿do not twist, kink, or sharply bend the driveline, system controller power cables, power module patient cable, or mobile power unit patient cable, which may cause damage to the wires inside, even if external damage is not visible.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 (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: 14550012
• MDR Text Key: 293540409
• Report Number: 2916596-2022-11092
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/18/2022
• Device Model Number: 106762
• Device Lot Number: 7015214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2019
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 107 KG