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

Model Number 1420

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591); Power Problem (3010)

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

Event Date 04/02/2018

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.Other devices involved in this event: heartware ventricular assist system -battery.Battery / (b)(4) /model #: 1650de / expiration date: 2017-03-31.Udi #: (b)(4).Return date: 2018-05-21.Device evaluation anticipated, but not yet begun.Mfg date: 2016-03-31.(b)(4).Heartware ventricular assist system -battery.Battery / (b)(4) /model #: 1650de / expiration date: 2017-04-30.Udi #: (b)(4).Return date: 2018-05-21.Device evaluation anticipated, but not yet begun.Mfg date: 2016-04-30.(b)(4).Heartware ventricular assist system -battery.Battery / (b)(4) /model #: 1650de / expiration date: 2019-01-09.Udi #: (b)(4).Return date: 2018-05-21.Device evaluation anticipated, but not yet begun.Mfg date: 2018-01-09.(b)(4).Heartware ventricular assist system -battery.Battery / (b)(4) /model #: 1650de / expiration date: 2017-03-31.Udi #: (b)(4).Return date: 2018-05-21.Device evaluation anticipated, but not yet begun.Mfg date: 2016-03-31.(b)(4).Heartware ventricular assist system -battery.Battery / (b)(4) /model #: 1650de / expiration date: 2017-03-31.Udi #: (b)(4).Return date: 2018-05-21.Device evaluation anticipated, but not yet begun.Mfg date: 2016-03-31.(b)(4).Heartware ventricular assist system -battery.Battery / (b)(4) /model #: 1650de / expiration date: 2018-11-30.Udi #: (b)(4).Return date: 2018-05-21.Device evaluation anticipated, but not yet begun.Mfg date: 2017-11-21.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the ventricular assist device (vad) controller and associated batteries exhibited power switching and critical battery alarms at a battery capacity greater than twenty-five percent (25%).The batteries and controller were exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the controller (b)(4) and batteries (b)(4) were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.The log files of the controller in use during the reported event, (b)(4), revealed that the controller contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Log file analysis did not reveal any premature power switching events or critical battery alarms involving the batteries.Failure analysis of the returned devices revealed that the devices passed visual examination and functional testing.As a result, the reported event could not be confirmed.Battery (b)(4).D4: expiration date: 2017-03-31 udi #: (b)(4).H3: yes h4: mfg date: 2016-03-31 h6 fda method code(s): 10, 4112 h6 fda results code(s): 213 h6 fda conclusion code(s): 67 battery (b)(4).D4: expiration date: 2017-04-30 udi #: (b)(4).H3: yes h4: mfg date: 2016-04-30 h5: no h6 fda method code(s): 10, 4112 h6 fda results code(s): 213 h6 fda conclusion code(s): 67 battery (b)(4).D4: expiration date: 2019-01-09 udi #: (b)(4).H3: yes h4: mfg date: 2018-01-09 h5: no h6 fda method code(s): 10, 4112 h6 fda results code(s): 213 h6 fda conclusion code(s): 67 battery (b)(4).D4: expiration date: 2017-03-31 udi #: (b)(4).H3: yes h4: mfg date: 2016-03-31 h6 fda method code(s): 10, 4112 h6 fda results code(s): 213 h6 fda conclusion code(s): 67 battery (b)(4).D4: expiration date: 2017-03-31 udi #: (b)(4).H3: yes h4: mfg date: 2016-03-31 h6 fda method code(s): 10, 4112 h6 fda results code(s): 213 h6 fda conclusion code(s): 67 battery (b)(4).D4: expiration date: 2018-11-30 udi #: (b)(4).H3: yes h4: mfg date: 2017-11-21 h6 fda method code(s): 10, 4112 h6 fda results code(s): 213 h6 fda conclusion code(s): 67 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 - CONTROLLER 2.0
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7557127
• MDR Text Key: 109757336
• Report Number: 3007042319-2018-02147
• 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: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• 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?: No
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(4).
• Patient Age: 69 YR