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

Model Number 106762

Device Problems No Display/Image (1183); Insufficient Information (3190)

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

Event Date 06/10/2021

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 patient came to emergency room and stated that the controller went black.The controller is now working and attached to monitor.There were no alarms in history, sending data for analysis.The log file captured routine events, there were no notable alarm conditions or parameter changes.The pump parameter¿s trending can be viewed in the graph below.In reference to the controller going dark, the log file did not show any issues with the controller.The controller was exchanged and returned.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a blank liquid crystal display (lcd) was not confirmed.A review of the log files spanned approximately 42 days (b)(6) 2021¿(b)(6) 2021 per time stamp).There were no notable alarms in the log file that would have resulted in any lcd related issues.The pump maintained a speed above the low speed limit (lsl) without issue throughout the log file while the driveline was connected.The heartmate ii system controller (serial (b)(6) was functionally tested and found to operate as intended during analysis.No atypical alarms or lcd issues were produced during testing.The controller was able to support pump function for an extended period of time.A root cause for the reported event cannot be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.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 heartmate ii instructions for use section 7 ¿alarms and troubleshooting¿ and heartmate ii patient handbook section 5 ¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot alarms including lcd faults.The heartmate ii instructions for use section 8, ¿equipment storage and care¿ and heartmate ii patient handbook section 6, ¿caring for the equipment¿ explain how to properly care for the system controller, including handing, transport, cleaning, and maintenance.The heartmate ii patient handbook instructs users to not twist, kink, or otherwise bend their system controller¿s power cords in a way that may damage them.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
• MDR Report Key: 12128537
• MDR Text Key: 260329971
• Report Number: 2916596-2021-03665
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: 00813024011286
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2020
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Device Lot Number: 6029941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 81