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

Model Number	1650
Medical Device Problem Codes	Battery Problem (2885); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that six batteries had a poor mechanical connection that were unable to be secured.It was also reported that one of those batteries also had a critical battery alarm when the battery capacity was at 85 percent.It was also reported that another battery had communication errors and power disconnect alarms.Six of the batteries were removed from service and one remains in use.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.Additional products: heartware ventricular assist system ¿ battery, model #: 1650/ catalog #: 1650/ expiration date: 31-mar-2021 / 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: 10-mar-2020, labeled for single use: no.(b)(4).Heartware ventricular assist system ¿ battery, model #: 1650/ catalog #: 1650/ expiration date: 31-mar-2021 / 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: 10-mar-2020, labeled for single use: no, (b)(4).Heartware ventricular assist system ¿ battery, model #: 1650/ catalog #: 1650/ expiration date: 31-mar-2021 / 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: 10-mar-2020, labeled for single use: no, (b)(4).Heartware ventricular assist system ¿ battery, model #: 1650/ catalog #: 1650/ expiration date: 31-mar-2021 / 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: 10-mar-2020, labeled for single use: no, (b)(4).Heartware ventricular assist system ¿ battery, model #: 1650/ catalog #: 1650/ expiration date: 31-mar-2021 / 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: 10-mar-2020, labeled for single use: no, (b)(4).Heartware ventricular assist system ¿ battery model #: 1650/ catalog #: 1650/ expiration date: 31-mar-2021 / 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: 10-mar-2020, labeled for single use: no, (b)(4).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.
Additional Manufacturer Narrative
A supplemental report is being submitted for device analysis an investigation completion.Product event summary: (b)(4) batteries ((b)(6)) were returned for evaluation.(b)(4) batteries ((b)(6)) were not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the returned devices in relation to the reported event.Failure analysis of the returned batteries revealed that the devices passed visual inspection and functional testing; the batteries were able to adequately connect to a controller with no anomalies observed.Log file analysis revealed that the controller in use during the reported event contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Review of the alarm log file did not reveal any power disconnect alarms within the analyzed period; however, review of the data log file revealed instances involving (b)(6), where the batteries' relative state of charge (rsoc) were between 101-201, which is indicative of communication errors.A communication error will trigger a power disconnect alarm if the other power source is a battery with a rsoc greater than 25%.Review of the alarm log file revealed one (1) critical battery alarm due to a communication error involving (b)(6).As a result, the reported communication error, critical battery alarm and power disconnect alarms events were confirmed.The reported poor mechanical connection event involving (b)(6), and (b)(6) was not confirmed.The reported poor mechanical connection event involving (b)(6) could not be confirmed.The batteries (b)(6) were lubricated prior to release.There is no evidence that a power source lubrication procedure was performed on (b)(6).Applicable risk documentation and experience with events of similar circumstances were considered, a possible root cause of the reported poor mechanical connection event can be attributed, but not limited, to connector damage.The most likely root cause of the reported critical battery alarm event can be attributed to a communication error between the controller and battery.Possible root causes of the communication errors, and resulting power disconnect alarms, can be attributed to a momentary disconnection on the communication pins of the controller, the controller not receiving responses from the batteries, and/or due to the packet error checking method detecting bit errors.Battery (b)(6) d9: yes, return date: 11-aug-2022 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 battery (b)(6) d9: yes, return date: 11-aug-2022 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 battery (b)(6) d9: yes, return date: 11-aug-2022 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c04 h6: fda conclusion code(s): d02 battery (b)(6) h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 battery (b)(6) d9: yes, return date: 11-aug-2022 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c04 h6: fda conclusion code(s): d02 battery (b)(6) h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c04 h6: fda conclusion code(s): d02 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: 14733784
• Report Number: 3007042319-2022-05441
• Device Sequence Number: 5800179
• Product Code: DSQ
• UDI-Device Identifier: 00888707006873
• UDI-Public: 00888707006873
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 10/31/2022

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: 03/31/2021
• Device Model Number: 1650
• Device Catalogue Number: 1650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2020
• 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: 1103 VAD
• Patient Age: 62 YR
• Patient Sex: Male