MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

Catalog Number 106524US

Device Problems Device Stops Intermittently (1599); Connection Problem (2900)

Patient Problem Dizziness (2194)

Event Date 06/09/2018

Event Type  Injury  

Manufacturer Narrative

Approximate age of device ¿ 86 days.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2018.It was reported that the lvad system produced an alarm.The patient panicked and attempted to perform a system controller exchange.The patient was unable to change system controllers and the pump was stopped for approximately 3 minutes during this time.The patient became dizzy and reconnected the lvad to the initial system controller in use.The lvad restarted and reportedly seemed to be functioning properly.A representative of the manufacturer¿s technical services reviewed the submitted log file and observed a system controller backup battery fault alarm.The technical services representative recommended that the system controller backup battery be replaced.The remainder of the log file appeared normal.It was reported that the system controller backup battery was replaced.The patient was re-educated on performing system controller exchanges.

Manufacturer Narrative

The reported driveline disconnect event was confirmed via the log file data provided by the customer.The controller event log file contained approximately 6 days of data.Backup battery fault alarms were captured, due to backup battery load test fails.The driveline was disconnected and was accompanied with lvad off alarms, which appeared consistent with the reported system controller exchange.The system controller was reconnected to the pump.The backup battery fault alarms persisted.No further atypical alarms were recorded.Despite the observed alarms, the log file data appeared to have captured the pump operating as intended.The hm3 lvas ifu and patient handbook explain that if the driveline disconnects from the system controller, the pump stops.If the driveline becomes disconnected from the system controller, it should be promptly reconnected to restart the pump.The pump cannot run without power.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 7661597
• MDR Text Key: 113153130
• Report Number: 2916596-2018-02679
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• 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: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 106524US
• Device Lot Number: 6278483
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SYSTEM CONTROLLER BACKUP BATTERY, (B)(4)
• Patient Outcome(s): Life Threatening
• Patient Age: 57 YR
• Patient Weight: 95