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

Model Number 1420

Device Problems No Display/Image (1183); Date/Time-Related Software Problem (2582); Power Problem (3010); Data Problem (3196)

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

Event Date 07/26/2019

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

Event Description

It was reported that the controller exhibited an unexpected power loss, the light emitting diodes would not illuminate when connected to power sources, exhibited a date format issue, and data was unable to transfer.The controller was exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: one (1) controller was 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 returned controller revealed that the device passed visual inspection.Functional testing revealed that the front panel battery capacity indicators did not illuminate.As a result, the reported "leds not illuminating" event was confirmed.Functional testing also revealed that the controller was unable to communicate with external batteries on both power ports, resulting in critical battery alarms.Internal inspection of the controller revealed a damaged diode on the communication line pertaining to power port 2.Additionally, it was observed that the integrated circuit responsible for the communication between the controller and batteries was damaged.The damaged integrated circuit is also connected to the real time clock circuit and may have caused the date and time stamp to remain frozen.As a result, the controller was unable to determine the capacity of the battery, causing the controller to trigger a critical battery alarm.Additionally, internal inspection of the controller revealed a crack on a standoff post within the controller housing.The observed crack on the standoff post is not related to the reported event.Based on an investigation, the root cause of the crack was determined to be due to mineral oil applied to the controller¿s internal main gasket and/or to the silicone adhesive applied around the controller¿s internal battery coming into contact with the standoff post.The mineral oil and/or silicone adhesive contributed to environmental stress cracking.Log files were able to be properly downloaded from the controller; as a result, the reported data transfer error event could not be confirmed.Log file analysis revealed a controller power up event on 25/jul/2019 at 17:39:44.The data point prior to the loss of power revealed that a battery was connected to power port one (1) with 51% relative state of charge (rsoc), and a battery was connected to power port two (2) with 99% rsoc.The data point recorded after the loss of power revealed that a controller power adapter was connected to power port 1, and no power source was connected to power port 2.The controller was without power for 16 seconds.Log file analysis also revealed multiple critical battery alarms logged with an incorrect date stamp and no battery capacity, id, or cycle count.As a result, the reported power loss event, controller display error and data format error events were confirmed.The most likely root cause of the controller display error can be attributed to communication errors between the controller and batteries.The most likely root cause of the incorrect date format error can be attributed to a damaged integrated circuit.A possible root cause for the damaged diode and integrated circuit on the communication line can be attributed to a misalignment of the cac adapter on power port 2 of the controller, causing a voltage spike on the communication pin of the connector.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 evaluation was initiated to capture events involving the controller losing power.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.

Manufacturer Narrative

A supplemental report is being submitted as remedial action and correction number information was received.If new information is received, the file will be re-opened and a supplemental will be submitted.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.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 (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8892906
• MDR Text Key: 154271413
• Report Number: 3007042319-2019-09080
• 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
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 09/19/2019; 03/06/2020
• Supplement Dates FDA Received: 09/20/2019; 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1428-2020
• Patient Sequence Number: 1
• Treatment: 1104 VAD.; 1104 VAD
• Patient Age: 72 YR
• Patient Weight: 62