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

Model Number 1401

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 01/20/2018

Event Type  Death  

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

Event Description

It was reported by the ventricular assist device (vad) coordinator, that the patient did not show up to an appointment last week, which was unlike her according to the coordinator.The coordinator called the patient and there was no answer, coordinator proceeded to call patient's employer, who informed site that the patient had passed away.Coordinator was able to get a hold of patient's aunt who informed her that patient was found dead at her home on (b)(6) 2018.The patient never showed up for a meeting with friends, and friends went to patients home and found her dead.According to the patient's aunt, it was stated that it seemed to happen suddenly, as there were groceries on counter, as patient had just arrived home from store and was found in the kitchen.The coordinator asked ifit was possible to get the equipment back, and the aunt said the only equipment that was able to be provided was what they had at the funeral home.The coordinator called funeral home and site is having a courier go to funeral home tomorrow to retrieve controller and batteries.Site will then send log files from controller.According to patient's aunt, the controller was not alarming when the patient was found.Coroner had pronounced patient dead at the patient's home.Site does not believe cause of death is directly related to vad.On (b)(6) 2018, log files were sent in and showed that there was a controller failed alarm on (b)(6) 2018 at 20:53.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis #(b)(4) :in relation to the reported event, device (b)(4) passed visual inspection and did not pass functional testing.Log files analysis revealed: a controller fault alarm was confirmied and logged on (b)(6) 2018 at 20:53:02.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: con004424: the controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the returned device in relation to the reported event.Failure analysis of the controller revealed that the unit passed visual examination.Functional testing revealed that the controller's "no power" alarm was silent when both power sources were disconnected from the controller due to a leakage detected within the internal battery that supplies power to the alarm.As a result, the most likely root cause of the failure of the "no power" alarm to sound can be attributed to a leaky internal battery.A review of controller log files revealed a controller failed alarm (sys_uic_comm_fail) was logged on (b)(6) 2018 at 20:53:02.The controller failed alarm was due to the user interface control integrated circuit losing communication to the pump motor control (pmc) integrated circuit.Following this alarm, the controller continued to operate on two batteries at a reduced rate of battery discharge, as a result of the pump not consuming power due to the pmc software malfunction.As a result, the reported event was confirmed.Of note, the controller did not have an electro-static-discharge (esd) shield.An internal investigation determined that the most probable root cause of the pmc software malfunction was due to electro-static-discharge (esd) from controllers that were manufactured prior to the implementation of the esd shield.As a result, the most likely root cause of the reported event can be attributed to an electro-static-discharge (esd) event, resulting in a loss of communication between the user interface controller and pump motor controller.The device remains implanted in the patient and is thus not available for return to the manufacturer.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.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.

• 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
• Manufacturer (Section G): HEARTWARE INC.; 14400 nw 60th ave.; miami lakes FL 33014
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7275036
• MDR Text Key: 100229496
• Report Number: 3007042319-2018-00643
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2012
• Device Model Number: 1401
• Device Catalogue Number: 1401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1731-2015, Z-1131-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 51 YR