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

Model Number 106531US

Device Problems Alarm Not Visible (1022); Complete Loss of Power (4015)

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

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of system controller failing to alarm was not confirmed.The system controller periodic log file spanned approximately 255 days ((b)(6) 2022 to (b)(6) 2023 per the timestamp).Ebb usage count increased from 12 to 69 between (b)(6) 2022 at 14:41 and (b)(6) 2023 at 14:20 due to loss of external power.Per provided information, the usage of backup battery was identified to be caused by faulty outlet while the device was connected to mobile power unit (mpu); however, the patient did not observe associating no external power alarm when the backup battery was used to operate the system.The periodic log file captures events at specific interval and did not capture the onset of the events.No other notable alarm was observed.The hm3 system controller, serial (b)(4), was not returned for analysis.A root cause of the reported event was not 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.Heartmate iii instructions for use section 7-¿alarms and troubleshooting¿ and heartmate iii patient handbook section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot alarms.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient experienced a lot of backup battery usages that could not be accounted for.It was noted that the patient had a 2.0 flow controller.The log files captured several low flow events on (b)(6) 2023 at 13:57 and 14:05.These events were in the presence of elevated pulsatility index (pi) values that were most likely patient related.It was noted that the backup battery usage count was 69.Due to persistent pi events the data capture was short and did not display any emergency backup battery (ebb) usage events.The cause of the ebb usage count increase was due to a faulty electrical outlet.The mpu was switched to a different electrical outlet.The patient noted that no alarms occurred.An electrician was scheduled to repair outlet.

• Brand Name: HEARTMATE 3 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: 16552563
• MDR Text Key: 311753916
• Report Number: 2916596-2023-01496
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• 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
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 8282534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2021
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 52 KG