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

Model Number 106531US

Device Problems Electrical Power Problem (2925); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that while preparing the heartmate 3 system controller for use, a backup battery fault appeared.The emergency backup battery (ebb) was reseated and the fault remained.The ebb was taken out of service and replaced with a new ebb.The backup battery fault initially resolved, but then returned.The vad coordinator replaced the heartmate 3 system controller, and it was reported that the malfunctioning controller would be returned for analysis.This was an out-of-box failure.There have not been any additional alarms since the controller was exchanged.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a backup battery fault alarm was confirmed.A review of the downloaded log file spanned approximately 3 days (16sep20 and 29dec20 ¿ 30dec20 per time stamp).The backup battery fault alarm activated on 29dec20 between 17:07 and 30dec20 at 10:45 while the black power cable was disconnected due to a circuit fault.The battery was replaced the first time the alarm activated but the alarm returned.No other notable alarms active in the log file.The returned system controller, serial number (b)(6) , was functionally tested and found to activate a backup battery alarm when the black power cable was disconnected.The controller backup battery ribbon cable had conductor breakdown in pin 11.Once the ribbon cable was replaced, the issue resolved.The controller was able to support pump function for an extended period of time.The root cause for the reported event was determined to be conductor breakdown in the backup battery ribbon cable.The patient handbook and ifu also 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 3 instructions for use section 7-¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5-¿alarms and troubleshooting¿ explain how to troubleshoot the system controller, including backup battery fault alarms.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11181183
• MDR Text Key: 228006799
• Report Number: 2916596-2021-00010
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• 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: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2023
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7707331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 82