MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0; VENTRICULAR (ASSIST) BYPASS

Model Number 1420

Device Problems Device Alarm System (1012); No Display/Image (1183)

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

Event Date 12/11/2018

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 and destination therapy 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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient heard a short alarm, but there was no indication of an alarm being sounded on the controller.The controller screen was blank and the alarm indicator did not light up.The controller remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the controller was not returned for evaluation.Log file analysis revealed that the controller contained a software feature that records whether a power source experienced a communication error or a disconnection within each 15 minute interval.Analysis of the data log files revealed momentary disconnections involving (b)(4), (b)(4), (b)(4), and (b)(4).Momentary disconnections will result in an audible tone.As a result, the reported "short alarm" event was confirmed.However the reported faulty display could not be confirmed as the device was not returned for evaluation.Applicable risk documentation and experience with events of similar circumstances were considered; events with display error can be attributed, but not limited, to a display connection failure, faulty component in the display circuitry of the printed circuit board and/or due to a faulty lcd display module.The most likely root cause of the reported "short alarm" event can be attributed to momentary disconnections between the controller and batteries.An internal investigation has been opened to evaluate momentary disconnections and implement corrective actions as required.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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 - CONTROLLER 2.0
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8171796
• MDR Text Key: 130639733
• Report Number: 3007042319-2018-07208
• 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: foreign,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1903-2018
• Patient Sequence Number: 1
• Treatment: (B)(4).