MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 1.0; VENTRICULAR (ASSIST) BYPASS

Model Number 1407GB

Device Problems Loose or Intermittent Connection (1371); Device Inoperable (1663); Device Displays Incorrect Message (2591); Power Problem (3010)

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

Event Date 03/07/2018

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 / (b)(4)/ model #: 1650de / expiration date: 2018-05-31 udi #:(b)(4), device evaluation anticipated, but not yet begun mfg date: 2017-05-31 (b)(4).Heartware ventricular assist system ¿ battery / (b)(4)/ model #: 1650de / expiration date: 2016-12-31 udi #: (b)(4), device evaluation anticipated, but not yet begun mfg date: 2015-12-31 (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the controller and batteries exhibited power switching with loss of power.The power switching occurred when one battery was connected to power port one of the controller.Subsequently, a steady continuous alarm occurred and the controller display went blank for a couple of seconds after the other battery was reconnected to power port two.In addition, power port one of the controller was loose.The controller was exchanged and the batteries remain in use.The pump parameters were noted to be stable following the controller exchange.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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.

Event Description

It was further reported that the batteries were exchanged.

Manufacturer Narrative

Product event summary: one (1) controller (b)(4) and two (2) batteries (b)(4) were returned for evaluation.The controller power ports were adequately sealed and could properly mate and lock when power sources were connected.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.

Manufacturer Narrative

Product event summary: two (2) batteries (b)(4) were returned for evaluation.One (1) controller (b)(4) was not returned for evaluation.A review of the manufacturing documentation confirmed that the associated controller met all requirements for release.Various analyses were conducted and reviewed in order to evaluate the performance of the batteries in relation to the reported event.Failure analysis of the returned batteries revealed that the devices passed visual examination and functional testing.Log file analysis 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.Analysis of the data log files revealed several premature power-switching events that were due to momentary disconnections involving (b)(4).Furthermore, log file analysis revealed a controller power up event on (b)(6) 2018, at 15:02:33.The data point prior to the loss of power revealed that (b)(4) was connected to power port one (1) and (b)(4) was connected to power port two (2).Several momentary disconnections were recorded leading up to the loss of power.The data point recorded after the loss of power revealed that (b)(4) was connected to power port (1) and (b)(4) was connected to power port two (2).The maximum controller off time was 14 minutes and 3 seconds.During a power loss event, the controller will alarm a continuous tone and the display will go blank.As a result, the reported power switching, loss of power and controller alarm events were confirmed; however, the reported loose controller power port event could not be confirmed due to insufficient evidence.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of loose power port connectors may be attributed to inadequate thread lock, an inconsistent thread lock cure time and an inadequate torque application during the assembly process.Based on the log file analysis, the most likely root cause of the premature power switching event can be attributed to momentary disconnections between the controller and batteries.A possible root cause of the loss of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.Internal investigations were initiated to capture events involving the controller losing power and momentary disconnections.Additional products: (b)(4).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 1.0
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7393465
• MDR Text Key: 104545142
• Report Number: 3007042319-2018-01289
• 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: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2018
• Device Model Number: 1407GB
• Device Catalogue Number: 1407GB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1903-2018
• Patient Sequence Number: 1
• Treatment: MCS UNKNOWN VAD
• Patient Age: 37 YR
• Patient Weight: 59