MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER; Ventricular (assist) bypass

Model Number 106531US

Device Problems No Audible Alarm (1019); Improper or Incorrect Procedure or Method (2017); Electrical Power Problem (2925); Complete Loss of Power (4015)

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

Event Date 01/22/2024

Event Type  malfunction  

Event Description

It was reported that the patient had a no external power alarm on (b)(6) 2024.On (b)(6) 2024 at 07:18:57, the patient connected to fully charged batteries.At 22:16:09, a low power advisory event occurred.At 22:16:46, a low power hazard event occurred.At 22:26:52, a no external power alarm occurred and the emergency backup battery was used the support the system until the power source was changed to a fully charged battery at 22:51:33.It was reported that the patient was unaware of any alarm going off.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a no external power alarm was confirmed via log file analysis.A review of the log file contained data spanning approximately 5 days ((b)(6) 2024 per timestamp).On (b)(6) 2024 at 22:16:09, low power advisory alarms activated due to routine battery depletion.At 22:16:46, the alarms transitioned into low power hazard and at 22:26:52 the alarms turned into no external power due to the external batteries becoming completely depleted.The backup battery supplied power to the system due to the loss of external power.The alarms resolved at 22:51:43 after fully charged batteries were connected.Pump operation was not affected.The heartmate 3 system controller (s/n: (b)(6)) was not returned for analysis.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The root cause for the reported event was unable to be conclusively determined through this analysis.Heartmate 3 instructions for use section 7 ¿ ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 ¿ ¿alarms and troubleshooting¿ covers all alarms (visual and audible), including power cable disconnect, low voltage, and no external power alarms, and the actions to take if the alarm cannot be resolved.Heartmate 3 instructions for use section 1 entitled ¿introduction¿ states that when fully charged, a pair of heartmate 14 volt lithium-ion batteries can power the system for up to 10¿17 hours, depending on the activity level of the patient.Heartmate 3 instructions for use and heartmate 3 patient handbook section 3, entitled ¿powering the system¿, explain the various ways to power the heartmate 3 lvas, and how to properly exchange power sources.It also states that at least one system controller power cable must be connected to a power source at all times and informs the user not to rely on the controller¿s backup battery, as it will only power the pump for a limited amount of time and the pump will stop.Heartmate 3 patient handbook cautions 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.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 (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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18669307
• MDR Text Key: 336186907
• Report Number: 2916596-2024-00690
• Device Sequence Number: 1
• Product Code: DSQ
• 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: Physician Assistant
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/05/2023
• Device Model Number: 106531US
• Device Lot Number: 7595485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2020
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 156 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American