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

Model Number	1650
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the battery exhibited a critical battery alarm when the battery was registering a 67% charge.The battery was replaced.No patient complications have been reported as a result of this event.
Additional 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 or Problem Description
It was further reported that the battery also exhibited a power disconnect alarm and a communication error.Another battery also exh ibited a few power disconnect alarms and communication errors and a critical battery alarm when the capacity was 44%.It was also noted that the controller exhibited a loss of power a few times.The battery was taken out of service and the controller remains in use.
Additional Manufacturer Narrative
A supplemental report is being submitted for additional event information.Additional products: d1: heartware ventricular assist system ¿ battery d4: model #:1650, catalog #: 1650, expiration date: 31-jan-2021, serial #:(b)(6), udi #:(b)(4).D9: no; h4: mfg date: 28-jan-2020; h5: no; h6: patient ime code(s): e2403; h6: imf code(s): f26; h6: img code(s): g02002; h6: fda device code(s): a0705; h6: fda method code(s): b21; h6: fda results code(s): c21; h6: fda conclusion code(s): d16; d1: heartware ventricular assist system ¿ controller 2.0 d4: model #:1420, catalog #:1420, expiration date: 31-dec-2020, serial #:(b)(6), udi #:(b)(4).Additional information has been requested regarding the status of the controller, but it was not available at the time of this report.If additional information is received, the event will be updated and a supplemental report will be sent.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.
Additional Manufacturer Narrative
###a supplemental report is being submitted for device evaluation.Additional products: serial #: (b)(6) d9: yes 03-aug-2022 h3: yes h6: fda method code(s): b01, b15 h6: fda results code(s): c04 h6: fda conclusion code(s): d02, d15 serial #: (b)(6) h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c04 h6: fda conclusion code(s): d15, d02 product event summary: one (1) battery (bat855001) was returned for evaluation.One (1) battery (bat851132) and a controller (con409549) 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 battery revealed that the device passed visual inspection and functional testing; the battery was able to adequately charge on a test battery charger with no anomalies observed.Review of the autologs report revealed three (3) controller power up and associated motor start event logged within (b)(6) 2022 at 19:23:49 and (b)(6) 2022 at 16:09:55, indicating a loss of power to the controller.The events leading up to the losses of power could not be determined since the raw log files covering the events were not available for analysis.Review of the available autologs report also revealed two (2) critical battery alarms logged with a battery capacity above 10% relative state of charge (rsoc) involving bat855001 and bat8511332, it is likely the alarms were due to communication errors between the batteries and controller.In addition, review of the available autologs report revealed four (4) power disconnect alarms involving bat855001 and bat8511332; however, the cause of the alarm could not be determined since raw log files were not available for analysis.As a result, the reported event was confirmed.The batteries had been lubricated prior to release.Applicable risk documentation, experience with events of similar circumstances, and the available information were considered; a possible root cause of the critical battery alarms involving batteries above 10% rsoc event may be attributed to communication errors between the controller and batteries.Possible root causes of the power disconnect alarms can be attributed, but not limited, to a communication error and/or a battery malfunction.A possible root cause of the observed loss of power event can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.Capa pr00551638 is investigating controller losses of power.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 - BATTERY
• Common Device Name: 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: 14594102
• Report Number: 3007042319-2022-05311
• Device Sequence Number: 2096005
• Product Code: DSQ
• UDI-Device Identifier: 00888707006873
• UDI-Public: 00888707006873
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2020
• Device Model Number: 1650
• Device Catalogue Number: 1650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 06/21/2022; 08/13/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 06/29/2022; 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4) VAD
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 78 KG