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

Model Number 1407DE

Device Problem Device Inoperable (1663)

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

Event Date 05/31/2018

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: 2018-07-31 udi #: (b)(4) return date: 2018-06-18 device evaluation anticipated, but not yet begun mfg date: 2017-07-31 (b)(4).Heartware ventricular assist system ¿ battery/ (b)(4)/ model #: 1650de / expiration date: 2018-07-31 udi #: (b)(4) return date: 2018-06-18 device evaluation anticipated, but not yet begun mfg date: 2017-07-31 (b)(4).Heartware ventricular assist system ¿ battery/ (b)(4)/ model #: 1650de / expiration date: 2018-07-31 udi (b)(4) return date: 2018-06-18 device evaluation anticipated, but not yet begun mfg date: 2017-07-31 (b)(4).Heartware ventricular assist system ¿ battery / (b)(4)/ model #: 1650de / expiration date: 2018-07-31 udi #: (b)(4) return date: 2018-06-18 device evaluation anticipated, but not yet begun mfg date: 2017-07-31 (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that four batteries were involved in power switching with a capacity greater than twenty-five percent, causing a loss of power to the controller and a pump stop event.Three of the batteries also had critical battery alarms.The batteries were exchanged and the controller remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: four batteries were returned for evaluation.The controller was not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported events.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 software with 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 file revealed several premature power switching events due to momentary disconnections involving all four batteries as well as premature power switching events due to communication errors involving (b)(4).Analysis of the alarm log file revealed three critical battery alarms due to communication errors involving (b)(4).Analysis of the event log file revealed two controller power up events, with associated motor start events, logged on may 23, 2018 at 18:55:49 and may 31, 2018 at 22:23:32, indicating losses of power to the controller.The data point prior to the first controller power up, logged at 18:41:14, revealed that (b)(4) was connected to power port 1 and (b)(4) was connected to power port 2; both batteries had experienced a momentary disconnection within the preceding 15 minutes.The data point after the controller power up event, logged at 18:56:24, revealed that (b)(4) was connected to power port 1 and (b)(4) was connected to power port 2.The controller was without power for 13 seconds.The data point prior to the second controller power up, logged at 22:20:43, revealed that (b)(4) was connected to power port 1 with 45% relative state of charge (rsoc) and (b)(4) was connected to power port 2 with 22% rsoc.The data point after the controller power up event, logged at 22:24:08, revealed that (b)(4) was connected to power port 1 and (b)(4) was connected to power port 2.The controller was without power for 14 seconds.As a result, the reported premature power switching, critical battery alarms, and loss of power events were confirmed.The most likely root cause of the premature power switching events can be attributed to communication errors and momentary disconnections between the controller and batteries.The most likely root cause of the critical battery alarms can be attributed to communication errors between the controller and battery.A possible root cause of the losses of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.An internal investigation examined momentary disconnections.A separate internal investigation was initiated to capture events involving the controller losing power.(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 2.0
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7651655
• MDR Text Key: 112872302
• Report Number: 3007042319-2018-02795
• 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
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2018
• Device Model Number: 1407DE
• Device Catalogue Number: 1407DE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1903-2018
• Patient Sequence Number: 1
• Treatment: 1104 VAD
• Patient Age: 67 YR
• Patient Weight: 85