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); Date/Time-Related Software Problem (2582); Battery Problem (2885)

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

It was reported that the controller exhibited a controller fault alarm due to a depleting internal battery.While two batteries were connected the controller did not indicate a power connection and a critical battery alarm occurred.The controller and batteries have been exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: heartware ventricular assist system ¿ battery model #: 1650de / catalog #: 1650de / expiration date: 30-sep-2019 / serial #: (b)(4).Udi #: (b)(4).Device available for evaluation: no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 06-sep-2018.Labeled for single use: no.(b)(4).Heartware ventricular assist system ¿ battery model #: 1650de / catalog #: 1650de / expiration date: 30-sep-2019 / serial #: (b)(4).Udi #: (b)(4).Device available for evaluation: no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 07-sep-2018.Labeled for single use: no.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that there was no controller fault alarm on the controller.However, the controller exhibited data time clock error.Also, the batteries exhibited communication errors and were at the end of life/passed 500 cycle counts.It was reported that there was a submission issue with sending logfiles, the site attempted to send the downloads the normal way but they did not go through.

Manufacturer Narrative

A supplemental report is being submitted for correction.Correction b5: the prior regulatory report, stated in the event description that the controller exhibited controller faults alarms.Upon secondary review the controller did not exhibited controller faults alarm.The event description was updated state that the controller did not exhibit controller fault alarm but it did exhibit real clock time error.Additional information, was added to the event description where the batteries exhibited communication error and were at their end of life, and there was a logfile submission error when the site was attempting to submit the logfiles.Correction h6: fda device code(s) was updated to include a1108.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 a correction to: -g.3)date mfr rec: corrected from blank to 09-dec-2021.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.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 an update to the following sections d <(>&<)> h and a correction to h10 additional product.Section d: -serial #: changed from (b)(6) to (b)(6) unique identifier# from asku to (b)(4).Section h.4: device mfg date: changed from 30-sept-2018 to 13-sept-2018.Additional products: d4: serial#: corrected from (b)(6) to (b)(6) udi#:(b)(4) 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 is being submitted for correction and additional information.Correction d4: serial # was corrected from (b)(6) to (b)(6).Correction h4: device mfg date was corrected from 13-sept-2018 to 11-sept-2018.Additional information was received regarding the product return of (b)(6).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 device evaluation and investigation completion.Product event summary: one (1) controller (con402781) was returned for evaluation.Two (2) batteries (b)(6) were not 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 controller was unable to properly communicate with external power sources; when connected to a battery, critical battery alarms were triggered.Additionally, when attempting to download the log files, the controller exhibited cyclical controller reset events.However, the controller was still able to receive power from both power sources.Functional testing also revealed an incorrect date/time on the controller display.Internal inspection revealed a damaged diode on the communication line and a damaged integrated circuit responsible for the communication between the controller and batteries.The damaged integrated circuit is connected to the main integrated chip responsible for the operations of the controller and may have caused the observed controller resets and is also connected to the real time clock circuit and may have caused the date/time stamp to remain frozen.After the faulty components were replaced, the controller performed as intended.Log file analysis revealed that the data file contained various corrupt entries in which the real time clock (rtc) was reset to the year ending 99.The corrupted data points had a time stamp of 31/feb/99 at 00:00:00.Review of the alarm log file revealed eighteen (18) critical battery alarms logged with a time stamp of 31/feb/99 at 00:00:00 and with a battery relative state of charge (rsoc) value of 101% logged and no serial number id, or cycle count, indicating that the controller was unable to recognize the connected batteries.As a result, the reported critical battery alarm, communication errors, time clock error and issue downloading log files events were confirmed, however, the reported batteries over 500 cycles event could not be confirmed.The reported batteries over 500 cycles can be attributed to the batteries reaching the end of their useful life.The most likely root case of the reported critical battery alarm, communication errors, time clock error and issue downloading log files events can be attributed to a damaged diode and damaged integrated circuit.A possible root cause for the damaged diode and integrated circuit on the communication line can be attributed to a voltage spike on the communication pin of the connector.Capa pr00465502 was opened to investigate this issue.Additional products: d4: serial #: (b)(6) h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d4: serial #: (b)(6) h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 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: 12924641
• MDR Text Key: 285634617
• Report Number: 3007042319-2021-08255
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2018
• 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-1428-2020
• Patient Sequence Number: 1
• Treatment: 1104 VAD