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

Catalog Number 1104

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 06/02/2013

Event Type  Injury  

Manufacturer Narrative

The hvad is used for treatment not diagnosis.The hvad pump driveline cable ((b)(4)) was not returned for analysis because it remains implanted.The reported event, driveline wire damage, was confirmed visually in the field by a heartware clinical engineer.It is possible that when the patient dropped the controller, the tensile force may have caused the pins to be disconnected from the contact block.After the driveline splice procedure was performed, the power and flow returned to normal and the patient is reported to be doing fine.The root cause for the reported driveline connector damage can be attributed to inadequate connector design specifications that does not account excessive pull force that may be exerted on to the driveline cable, causing the connector pins to recess and interrupt pump operation.The manufacturer has an open internal investigation for the retraction of the driveline cable splice connector pins.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.Per ifu provides an instruction and also a caution note: do not pull, twist or kink the driveline or power cables, especially while sitting, getting out of bed, adjusting controller or power sources, or when using the shower bag.It also cautions, "keep extra driveline length tucked under clothing or secured with an abdominal binder or dressing.Do not let any portion of driveline hang freely where it might get caught on external items such as doorknobs or the corners of furniture.Heartware is submitting this correction to a previously submitted mdr 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.(b)(4).

Event Description

It was reported that the patient accidently dropped the controller to the floor experiencing electrical fault alarms, followed by several pump stops.Motor disconnect was displayed on controller screen.Site agreed to perform a driveline splice.Site stated "splice repair was done using a y-cable.During the opening the tube the remaining wires has been recessed out of the connector block this resulted in a pump stop".Once reinsertion of the pins was performed the pump restarted successfully.The problem was resolved without patient injury.The product remains implanted and is not available for evaluation.All relevant and available information was provided.

• 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: nathalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 6039675
• MDR Text Key: 57815886
• Report Number: 3007042319-2016-03674
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/06/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2013
• Initial Date FDA Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1604-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention