MAUDE Adverse Event Report: ABBOTT LABORATORIES/THORATEC CORP. ABBOTT HEARTMATE 3; VENTRICULAR (ASSIST) BYPASS

Device Problem Device Alarm System (1012)

Patient Problem Dizziness (2194)

Event Date 03/27/2022

Event Type  Injury  

Event Description

Abbott heartmate 3 ventricular assist device, a mechanical heart pump surgically implanted into patients with advanced heart failure.On the date of the event the patient had "ongoing pi events without alarms prior to controller change (b)(6).Low flow alarm this am with loss of green power light on controller and patient symptomatic with lightheadedness/dizziness.Controller change completed (b)(6)." loss of the green power light indicates pump stoppage.Per logfiles from the event: the pump didn't stop until the driveline (from the pump) disconnected from the controller.Treatment dates/therapy dates: start (b)(6) 2018.Is therapy still on-going? yes.Diagnosis for use: hfref.Event abated after use stopped or dose reduced? yes.Fda safety report id # (b)(4).

• Brand Name: ABBOTT HEARTMATE 3
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): ABBOTT LABORATORIES/THORATEC CORP.
• MDR Report Key: 13967479
• MDR Text Key: 288394743
• Report Number: MW5108663
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White