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

Model Number 1403US

Device Problems Display or Visual Feedback Problem (1184); Loose or Intermittent Connection (1371); Battery Problem (2885)

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

Event Date 10/01/2017

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 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 #: 1650 / expiration date: 2018-04-30 udi #: (b)(4), device evaluation anticipated, but not yet begun mfg date: 2017-04-30 (b)(4).This event was assessed and is being reported as part of a retrospective review of log file data.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient heard an alarm then grabbed the battery connections, wiggled them and the alarm went away.Port 1 on the controller was stated to be loose and the controller was exchanged.Patient had a critical battery alarm.A log file review confirmed the critical battery alarm.The battery remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

Product event summary #the controller (b)(4) and the battery (b)(4) were not returned for evaluation.Log file analysis revealed one power disconnect alarm and 2 critical battery alarms, one of the critical battery alarms was involving (b)(4).In each instance, the battery went from a high relative state of charge (rsoc) to 0% rsoc.The power disconnect alarm was probably related to the reported ¿patient heard an alarm¿.As a result, the reported alarms were confirmed.However, the reported loose connector could not be confirmed.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.The most likely root cause of the power disconnect and critical battery alarms can be attributed to a communication errors between the controller and battery.Additional products: battery/ (b)(4).H6 fda method code(s): 4112, 4114 h6 fda results code(s): 3213 h6 fda conclusion code(s): 12 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 (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7724310
• MDR Text Key: 115356008
• Report Number: 3007042319-2018-03296
• Device Sequence Number: 0
• Product Code: DSQ
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Model Number: 1403US
• Device Catalogue Number: 1403US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1751-2015
• Patient Sequence Number: 1
• Treatment: (B)(4).
• Patient Age: 64 YR