MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE VENTRICULAR ASSIST SYSTEM; CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE

Catalog Number 1407DE

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2016

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 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.The instructions for use (ifu) and patient manual include a reference guide for both visual and tone alarms including potential causes and actions to take.Additionally there is a warning to keep spare, fully charged batteries and back up controller available at all time.The steps for exchange of batteries and controllers are outlined.Heartware will submit a supplemental report if new facts arises which materially alters information submitted in a previous mdr report.

Event Description

It was reported that the controller battery display failed from time to time.This occurred with different batteries.  there were no reports of alarms.  the site is unsure if the issue was with the controller or the batteries.  log files were downloaded and the controller and six batteries were exchanged without consequence to the patient.  no further information was provided.

Manufacturer Narrative

The clinical specialist indicated that when the two batteries were connected to the controller the controller displayed the message [power disconnect] [reconnect power].If the test button was pressed, no lights appeared on the battery capacity display.After an undefined time, the battery began working again.The issue was resolved with the replacement devices.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Manufacturer Narrative

The controller and six batteries were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Analysis of the controller and batteries revealed that the devices met specifications; the units passed visual examination and functional testing, however (b)(4) did not pass functional testing as it caused the battery charger's status light to flash red when connected.Test equipment was unable to read the battery status due to a communication problem with the main integrated circuit.Internal inspection of the battery did not reveal any abnormalities that may have contributed to the inability to communicate to the main integrated circuit.An attempt to reset the main integrated circuit (ic) was able to re-establish communication with the ic.The most likely root cause of the reported event can be attributed to a faulty integrated circuit that controls the battery.An attempt was made to replicate the issue by manipulating the battery's connection to the controller during the analysis of all the units.Results revealed that the electrical connection between the batteries and the controller was stable.Log file analysis revealed that the controller contained the smr software.The software upgrade contains 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).The most likely root cause of the reported event can be attributed to momentary disconnections between the controller and batteries.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.Battery - (b)(4) / 1650de / manufacturing date: 03/13/2015 / expiration date: 03/31/2016 / (b)(4).Battery - (b)(4) / 1650de / manufacturing date: 09/06/2015 / expiration date: 09/30/2016 / (b)(4).Battery - (b)(4) / 1650de / manufacturing date: 03/11/2015 / expiration date: 03/31/2016 / (b)(4).Battery - (b)(4) / 1650de / manufacturing date: 04/15/2015 / expiration date: 04/30/2016 / (b)(4).Battery - (b)(4) / 1650de / manufacturing date: 03/11/2015 / expiration date: 03/31/2016 / (b)(4).Battery - (b)(4) / 1650de / manufacturing date: 09/20/2014 / expiration date: 09/30/2015 / (b)(4).

Manufacturer Narrative

The controller and six batteries were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Failure analysis of the controller and batteries revealed that the devices passed visual examination and functional testing, however (b)(4) did not pass functional testing as it caused the battery charger's status light to flash red when connected.Test equipment was unable to read the battery status due to a communication problem with the main integrated circuit.Internal inspection of the battery did not reveal any abnormalities that may have contributed to the inability to communicate to the main integrated circuit.An attempt to reset the main integrated circuit (ic) was able to reestablish communication with the ic.The most likely root cause of the reported event can be attributed to a faulty integrated circuit that controls the battery.An attempt was made to replicate the issue by manipulating the battery's connection to the controller during the analysis of all the units.Results revealed that the electrical connection between the batteries and the controller was stable.Log file analysis revealed that the controller contained the smr software.The software upgrade contains 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).The most likely root cause of the reported event can be attributed to momentary disconnections between the controller and batteries.Heartware has opened an internal investigation to evaluate the controller intermittent disconnections identified on smr-loaded controllers.The reported event of a faulty display on the controller could not be verified, the display operated as expected and did not fail during the failure analysis of the controller.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Manufacturer Narrative

(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
• Type of Device: CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• MDR Report Key: 6152978
• MDR Text Key: 61707645
• Report Number: 3007042319-2016-04353
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 1407DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Date Manufacturer Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BATTERY/(B)(4); BATTERY/(B)(4); BATTERY/(B)(4); BATTERY/(B)(4); BATTERY/(B)(4); BATTERY/(B)(4); BATTERY/(B)(4); BATTERY/(B)(4); BATTERY/(B)(4); BATTERY/(B)(4); BATTERY/(B)(4); BATTERY/(B)(4)