MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM; CIRCULATORY ASSIST SYSTEM

Catalog Number 1104

Device Problems Insufficient Flow or Under Infusion (2182); Cut In Material (2454); Connection Problem (2900)

Patient Problems Low Cardiac Output (2501); No Information (3190)

Event Date 11/26/2014

Event Type  malfunction  

Event Description

Approximately six months post hvad implantation, the patient initially presented with low flows and electrical faults.A controller exchange was performed, but the e-faults persisted.After further inspection of the driveline, a splice repair was performed.Investigation is ongoing.

Manufacturer Narrative

Device remains implanted.

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Dob (b)(6) 1960.Adverse event.It was reported that the patient was taken by air ambulance to the implant center for repair of the driveline which he had inadvertently cut.Service report dated (b)(4) 2014: inspections showed damage in the outer sheath close to exit site.It was unclear if the patient or the site removed previous sheath repair.X-rays indicated potential recessed pins inside the driveline tube.It was reported on (b)(4) 2014, "faults are resolved.Patient doing well." x-rays- unknown dates.Preliminary log files - - normal power consumption operating on single stator.267 low flow alarms have been logged since november 14, 2014.The current low flow alarm limit is set to 1.0 lpm.2 vad disconnect alarms have been logged at the following times: (b)(6) 2014 at 19:12:34; (b)(6) 2014 at 12:26:07; 33 electrical fault alarms have been logged since (b)(6) 2014.Please note change in viscosity on (b)(6) 2014.Reviewed on (b)(4) 2014.Concomitant medical products: updated: controller catalog/part no.To 14063us.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• Type of Device: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 310
• Manufacturer (Section G): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 310
• Manufacturer Contact: kathleen jacobson ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641562
• MDR Report Key: 4348812
• MDR Text Key: 21769748
• Report Number: 3007042319-2014-01362
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2014
• 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
• Treatment: CONTROLLER - (B)(4)