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

Model Number 1420

Device Problems No Display/Image (1183); Power Problem (3010); Data Problem (3196)

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

Event Date 02/25/2019

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.Concomitant medical products: 1103 vad, implanted: (b)(6) 2016.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by the patient that the controller had been alarming with the screen grayed out.The patient also reported that connecting to different power sources would not resolve the alarm and the controller would intermittently indicate it was connected to ac power even though the controller was on battery power.At the clinic, the controller was not able to download or display data.When the controller was connected to a single battery source, both battery power indicator lights would be fully illuminated, and the ac source indicator would blink.The controller was exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the returned device in relation to the reported event.A review of the manufacturing documentation confirmed that the associated controller met all requirements for release.Failure analysis of the returned controller revealed that the device passed external visual inspection.Functional testing revealed that the controller's liquid crystal display (lcd) was not functioning as expected; the display did not illuminate and all the leds on the front panel were on.Additionally, functional testing revealed that the controller was unable to communicate to a monitor and was unable to detect an alarm adapter connected to the serial port.Supplemental testing revealed that the faulty lcd was affecting the functionality of the user interface controller (uic), which is the main integrated chip responsible for the operations of the controller.Additionally, internal visual inspection revealed that the electrostatic discharge (esd) ground plate was missing and there was damage to the internal speaker connector.The lcd display module was replaced with a known working component, after which the controller was able to function properly.As a result, the reported event was confirmed.Based on the available information, the most likely root cause of the reported event can be attributed to a faulty lcd display module, which further affected the uic.A possible root cause of the missing esd ground plate and speaker damage can be attributed to improper assembly.The missing esd ground plate may have allowed for an esd event, which may have contributed to the failure of the lcd display module.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: 8420110
• MDR Text Key: 138772839
• Report Number: 3007042319-2019-04999
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000420
• UDI-Public: 00888707000420
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 07/02/2019
• Supplement Dates FDA Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: D314VRG ICD, 694765 LEAD; D314VRG ICD, 694765 LEAD
• Patient Age: 66 YR