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

Model Number 106762

Device Problem Premature Discharge of Battery (1057)

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

Event Date 07/12/2021

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 the patient had controller battery replaced in (b)(6) 2021 however the battery fault continued.It was determined that the controller was causing early battery fault therefore the controller was exchanged.No additional information provided.

Manufacturer Narrative

Manufactures investigation conclusion: there were incidental findings of wire fatigue.The reported event of a vertical white line on the lcd screen and backup battery fault alarm was confirmed.The log file spanned approximately 34 days ((b)(6) 2020 per the timestamp).Backup battery fault alarm (error code 38) activated on (b)(6) 2021 at 06:44 due to load test failure.The alarm did affect the controller¿s ability to operate the pump at the set speed limit, and resolved after the controller was shut down on (b)(6) 2021 at 11:15.The driveline was disconnected on (b)(6) 2021 at 11:15 for a controller exchange.No other notable alarm was observed.Initial inspection of the hm2 system controller, serial (b)(6) , revealed a vertical white line on the lcd screen which did not affect the functionality of the controller.The lcd screen was replaced with a test lcd which resolved the issue.The controller was functionality tested and connected to a mock circulatory loop for extended period of time without any issue.Backup battery fault alarm was not reproduced during the analysis.A root cause of the reported event was not determined through this analysis.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.Heartmate ii instructions for use section 7-¿alarms and troubleshooting¿ and heartmate ii patient handbook 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot alarms including low voltage advisory and power cable disconnect.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 maintain the integrity of the system controller.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.(b)(6) was shipped to the customer on 02nov2019.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: 12288564
• MDR Text Key: 265432505
• Report Number: 2916596-2021-04086
• 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: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/10/2022
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Device Lot Number: 7116672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 68