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

Catalog Number 1403US

Device Problems Detachment Of Device Component (1104); Electrical /Electronic Property Problem (1198)

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

Event Date 05/29/2017

Event Type  malfunction  

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.The hvad controller is a microprocessor unit that controls and manages the hvad system operation.It sends power and operating signals to the blood pump and collects information from the pump.The hvad controller requires two power sources for safe operation.The instructions for use (ifu) and patient manual explain the correct method of connecting to and disconnecting from the power sources and the controller to prevent damage to either the power source connections or the controller power ports.According to the ifu and patient manual, damaged equipment should be reported to the manufacturer and inspected.If the controller is only connected to one power source, the controller will function, but will sound an alarm after twenty seconds.In addition, the user is cautioned to always have a backup controller available and programmed identically to the primary controller.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.Evaluation is in progress.

Event Description

It was reported that assessment of the controller noted that the rubber cap on the data port was missing.The patient indicated that the cap fell off and it was not able to be placed back on.It was determined that the controller should be replaced, as it was not safe for the patient to have an open port.The controller was exchanged.The patient tolerated the exchange well, and experienced minimal pump off time.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.The reported event was confirmed during visual inspection.Failure analysis of the returned device revealed that the device failed visual inspection due to that the serial port cap was missing.A most likely root cause of the reported event can be possibly attributed to the handling of the controller.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Event Description

It was further reported that several electrical fault alarms were logged.

Manufacturer Narrative

This event was assessed and is being reported as part of a retrospective review of log file data.Correction: date of event, event, initial reporter name and address, pma/510k, and evaluation codes.Product event summary: the controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Failure analysis of the returned device revealed that the controller passed functional testing.Visual inspection revealed the serial port data cap was missing.Log files analysis revealed that ten (10) electrical fault alarms were logged from may 29, 2017 to may 30, 2017.The electrical fault alarms were indicative of an open phase in the rear stator.As a result, the reported event was confirmed.A most likely root cause of the reported missing serial data cap event can be possibly attributed to the handling of the controller.Based on the available information, a possible root cause of electrical fault alarms can be attributed, but not limited, to contamination by foreign material of the driveline connector or a marginal driveline connection.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• Type of Device: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE; 14400 nw 60th avenue; miami lakes FL 33014 3105
• MDR Report Key: 6654232
• MDR Text Key: 78132987
• Report Number: 3007042319-2017-01960
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: 1403US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR