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

Catalog Number 1103

Device Problems Cut In Material (2454); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2014

Event Type  malfunction  

Event Description

It was reported that a patient reported electrical fault alarms.A controller exchange was completed with no resolution of alarms.The patient indicated that he had accidentally cut the driveline while doing a dressing change.It was also reported that log files confirmed the issue with the patient's driveline.A temporary pump stop was required for repair.This procedure was completed in the or and the patient tolerated the repair procedure well.

Manufacturer Narrative

The site has indicated that the pump remains implanted, therefore it will not be returned.Device was used for treatment, not diagnosis.Ifu includes: perform exit site care every 24-48 hours using an antiseptic cleansing agent, such as a diluted chlorhexidine scrub solution.Following aseptic cleansing, rinse and dry the site to avoid tissue injury.Aseptic technique should be followed anytime the dressing is removed and the exit site is exposed, inspected, dressed or handled.When performing exit site care, be sure to wear a cap, mask and sterile gloves.Always examine the driveline for evidence of tears, punctures or breakdown of any of the material during exit site dressing changes.Driveline damage may affect heartware® system performance.Perform exit site care every 24-48 hours using an antiseptic cleansing agent, such as a diluted chlorhexidine scrub solution.Following aseptic cleansing, rinse and dry the site to avoid tissue injury.Aseptic technique should be followed anytime the dressing is removed and the exit site is exposed, inspected, dressed or handled.Product remains implanted.

Manufacturer Narrative

The hvad is used for treatment not diagnosis.It was reported that the patient accidentally cut through the driveline wires and began getting "electrical fault" alarms.The log files were sent to the manufacturer, which confirmed the issue with the patient's driveline.Representatives from the manufacturer traveled to the site to evaluate the driveline and confirmed superficial sheath damage and exposed damaged driveline wires, resulting in a sheath repair and splice procedure, respectively.There was no issue getting the pump to restart and the patient tolerated the procedure well.The root cause for "driveline wire damage" is improper handling/misuse by the user.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, including transportation.The instructions for use and patient manual outline the steps for handling and properly connecting power sources, including ensuring proper alignment, as well as instructions not to twist or force connections together in order to prevent damages.It is outlined to inspect the power connections and pins once a week, one at a time when changing the power source.Additionally there is a warning to keep spare, fully charged batteries and back up controller available at all time with a warning to switch to the back-up controller if there is a controller failure the steps for exchange of devices are also outlined.It further warns that damaged equipment should be reported to the manufacturer and inspected.Heartware is submitting this report as a result of remediation activities related to fda warning letter fla-14-14, dated june 2, 2014, and pursuant to the provisions of 21 cfr part 803.

• 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 3105
• Manufacturer (Section G): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer Contact: tatyana chorny ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641476
• MDR Report Key: 4333927
• MDR Text Key: 18798269
• Report Number: 3007042319-2014-01323
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 54 YR