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

Model Number	1650-
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional 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.Additional products: heartware ventricular assist system ¿ battery, model #: 1650 / catalog #: 1650 / expiration date: 31-oct-2016 / 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: 31-oct-2016.Labeled for single use: no.(b)(4).Additional products: heartware ventricular assist system ¿ battery, model #: 1650/ catalog #: 1650 / expiration date: 31-oct-2016 / 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: 15-oct-2015.Labeled for single use: no.(b)(4).Additional products: heartware ventricular assist system ¿ battery, model #: 1650 / catalog #: 1650 / expiration date: 31-dec-2016 / 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: 31-dec-2015.Labeled for single use: no.(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the batteries exhibited erroneous critical battery alarm and power disconnect alarms.The batteries were replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the four batteries not returned for evaluation.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.Analysis of the alarm log files did not reveal any power disconnect alarms.As a result, the reported power disconnect alarm events could not be confirmed.However, review of the data log file revealed multiple instances involving (b)(6) where the battery's relative state of charge (rsoc) values were logged between 101-201, which is indicative of communication errors.As a result, the reported power disconnect alarms could not be confirmed; however, the observed communication errors are likely related to the reported power disconnect alarms.Additionally, analysis of the alarm log files revealed several critical battery alarms due to communication errors involving (b)(6).As a result, the reported critical battery alarms were confirmed.A power source lubrication procedure was performed on the batteries on 23-jul-2018.The most likely root cause of the reported critical battery alarms can be attributed to communication errors between the controller and batteries.Possible root causes of the communication errors can be attributed to momentary disconnections 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.Additional products: d4: serial #: (b)(6) h3: yes.H6: fda method code(s): 4112, 4114.H6: fda results code(s): 3213.H6: fda conclusion code(s): 4307.D4: serial #: (b)(6).H3: yes.H6: fda method code(s): 4112, 4114.H6: fda results code(s): 3213.H6: fda conclusion code(s): 4307.D4: serial #: (b)(6).H3: yes.H6: fda method code(s): 4112, 4114.H6: fda results code(s): 3213.H6: fda conclusion code(s): 4307.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 (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9476628
• Report Number: 3007042319-2019-14525
• Device Sequence Number: 16869672
• Product Code: DSQ
• UDI-Device Identifier: 00888707000376
• UDI-Public: 00888707000376
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2016
• Device Model Number: 1650-
• Device Catalogue Number: 1650-
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1103 VAD
• Patient Age: 79 YR