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

Model Number 1420

Device Problems Device Alarm System (1012); Display or Visual Feedback Problem (1184); Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.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.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.

Event Description

It was reported that the controller had a loose component and exhibited intermittent critical battery alarms with two fully charged batteries.It was noted that power port one came off completely.The controller will be exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

###additional supplemental is being submitted as a correction, h10 has been updated to capture both batteries.Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: d1: heartware ventricular assist system ¿ battery d4: model #: 1650de / catalog #: 1650de / expiration date: unknown / serial #: unknown h3: no, device evaluation anticipated, but not yet begun h4: mfg date: unknown h5: no h6: patient ime code(s):e2403 h6: imf code(s): f26 h6: fda device code(s): a0705 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 d1: heartware ventricular assist system ¿ battery d4: model #: 1650de / catalog #: 1650de / expiration date: unknown / serial #: unknown h3: no, device evaluation anticipated, but not yet begun h4: mfg date: unknown h5: no h6: patient ime code(s):e2403 h6: imf code(s): f26 h6: fda device code(s): a0705 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 ### 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.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.

Event Description

It was further reported that the controller display kept popping up a message following the alarms.

Manufacturer Narrative

A supplemental report is being submitted for additional information.Newly received information indicates that the controller d isplay had a message that kept popping up.Investigation of this event is pending and a supplemental report will be sent upon its completion.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.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.

Manufacturer Narrative

A supplemental report is being submitted for investigation summary.Additional product: serial# unknown h6:fda method code(s): b15, b17 h6:fda result code(s): c19 h6:fda conclusion code(s): d14 serial# unknown h6:fda method code(s): b15, b17 h6:fda result code(s): c19 h6:fda conclusion code(s): d14 product event summary: one (1) controller (con409147) was returned for evaluation.Two (2) batteries with unknown serial number was not returned for evaluation.A review of the controller¿s manufacturing documentation confirmed that the associated device met all requirements for release.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 returned controller revealed a loose, detached power port one (1) connector.Functional testing also revealed that the controller was unable to communicate with the external batteries, exhibited controller reset events, the controller was unable to communication with the monitor, and the controller triggered a critical battery alarm during bench testing.Internal visual inspection revealed a loose metal locknut from power port one (1) in the controller; internal inspection did not reveal evidence of fluid ingress.A visual inspection under 10x magnification revealed that the thread of the connector did not have an application of the loctite substance, resulting in the loose component.Analysis indicated that the loose locknut likely caused a short circuit condition, resulting in damaged components, including a damaged diode on the communication line and damage to the integrated circuit responsible for the communication between the controller and batteries.Despite the inability to communicate with the batteries, the controller was still able to accept power from the batteries.Review of data log file revealed multiple data points with a battery relative state of charge (rsoc) value of 0% logged with incorrect date/time stamps and no serial number ids or cycle counts, indicating that the controller was unable to recognize the connected batteries.Review of the controller log files revealed multiple critical battery alarms logged with incorrect date stamps and no battery capacity, serial number id, or cycle count.Log file analysis also revealed multiple controller reset events with an incorrect date and time stamp.The damaged integrated circuit prevented the controller from reading battery information and caused the controller to trigger the critical battery alarms, as well as the controller reset events.It is likely the short circuit condition triggered the critical battery alarm and controller resets observed during bench testing.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 reported events were confirmed.The most likely root cause of the reported loose power port event can be attributed to improper assembly.Capa pr00508470 was opened to investigate loose connectors with controller 2.0.Based on the investigation conducted, the most likely root cause of the reported critical battery alarms, display error, observed real clock time issue, and observed controller reset events can most likely be attributed to damaged internal components caused by the loose locknut coming in contact with the controller's printed circuit board.Investigation of this event is completed and the file will be closed.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.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
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 16319205
• MDR Text Key: 309032223
• Report Number: 3007042319-2023-00940
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707006859
• UDI-Public: 00888707006859
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 1103 VAD
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 45 KG