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

Model Number 1650

Device Problems Battery Problem (2885); Material Integrity Problem (2978)

Patient Problems Anxiety (2328); Distress (2329)

Event Type  malfunction  

Event Description

It was reported that the patient had four batteries that failed on the same day and had only one battery and the ac adapter for use.The first battery was not charging and was not recognized by the controller.The second battery did not provide power and was also not recognized by the controller.The third battery was recognized by the control unit but was not charging properly when placed on the charging station.It was further reported that a fourth battery was causing unknown problems.It was noted that the patient was extremely distressed and scared.All the batteries were replaced.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#: 1650 / catalog#: 1650 / expiration date: 31-aug-2022 / serial#: (b)(4) udi #:(b)(4); deviceevaluated: no mfg date: 12-aug-2021 labeled for sigle use: no.Heartware ventricular assist system ¿ battery : model#: 1650 / catalog#: 1650 / expiration date: 30-apr-2022 / serial#: (b)(4) udi#: (b)(4) device evaluated: no : mfg date: 26-apr-2021 labeled for single use: no.Heartware ventricular assist system ¿ battery model#: unk / catalog#: unk / expiration date: unk / serial#: unknown udi#: unk device evaluated: no mfg date: unk labeled for single use: no.Additional information has been requested regarding the 4th battery serial#, clarification and allegation of the event, 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.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

###a supplemental report is being submitted as additional information on the fourth unknown battery has being received.Updated section: b5 desc evt problem 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 further reported that there were only three batteries involved, and there were no allegations against the fourth battery.

Manufacturer Narrative

###a supplemental is being submitted for additional information.Updated sections: - h10: updated the fourth unknown battery from "unknown" to (b)(6) with expiration date and manufacturing date, model number and udi number despite having no allegations against this fourth battery.Additional products: (b)(6) ¿ battery d9: yes, 2021-jul-06 h3: yes h6: fda method code(s): b01, b15 h6: fda results code(s): c02 h6: fda conclusion code(s): d01 (b)(6) ¿ battery d9: yes, 2021-jul-06 h3: yes h6: fda method code(s): b01, b15 h6: fda results code(s):c19 h6: fda conclusion code(s): d14 d1: heartware ventricular assist system ¿ battery d4: model#: 1650/ catalog#: 1650/ expiration date: 2021-jan-31 / serial#: (b)(6) udi#: (b)(4) d9: yes, 2021-jul-06 h3: yes h4: 2020-jan-20 h6: fda method code(s): b01, b15 h6: fda results code(s): c02 h6: fda conclusion code(s): d01 product event summary: four (4) batteries ((b)(6)) were returned for evaluation.No performance allegations were made against (b)(6).Various analyses were conducted and reviewed to evaluate the performance of the devices in relation to the reported event.Log file analysis associated with (b)(6) did not reveal any anomalies involving batteries.Failure analysis of the returned (b)(6) and (b)(6) revealed that the batteries passed visual inspection and functional testing.Failure analysis of (b)(6) and (b)(6) revealed that the batteries passed visual inspection.Functional testing of (b)(6) and (b)(6) revealed that the batteries were unable to charge or provide power due to an enabled zero-volt charge (zvchg) field-effect transistors (fets).The gas gauge is not programmed to use the zvchg fet, which indicates that the batteries unintentionally enabled the fets.The zvchg fet disables the charge and discharge fets, rendering the batteries inoperable.As a result, the reported not charging and battery not recognized event involving (b)(6) was confirmed.The reported events involving (b)(6) and (b)(6) could not be confirmed.Based on an investigation conducted under capa (b)(4) , the most likely root cause of the observed inability of the batteries to charge and provide power events involving (b)(6) and (b)(6) can be attributed to the battery connector interface design which does not guarantee the desired connection angle in some use conditions.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
• 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: 14794025
• MDR Text Key: 301981446
• Report Number: 3007042319-2022-05508
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707008778
• UDI-Public: 00888707008778
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Model Number: 1650
• Device Catalogue Number: 1650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• 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: MCS UNKNOWN VAD