MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0; VENTRICULAR (ASSISST) BYPASS

Model Number 1420

Device Problems Battery Problem (2885); Contamination /Decontamination Problem (2895); Connection Problem (2900)

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

Event Date 05/31/2022

Event Type  malfunction  

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-apr-2022 / serial #: (b)(4).Udi #: (b)(4), no device evaluation anticipated, but not yet begun, mfg date: 11-apr-2021.(b)(4), heartware ventricular assist system ¿ battery model #: 1650de/ catalog #: 1650de/ expiration date: 31-aug-2022 / serial #: (b)(4).Udi #: (b)(4).Device evaluation anticipated, but not yet begun, mfg date: 19-aug-2021, (b)(4).Heartware ventricular assist system ¿ battery model #: 1650de/ catalog #: 1650de/ expiration date: 31-aug-2022, serial #: (b)(4).Udi #: (b)(4).Device evaluation anticipated, but not yet begun mfg date: 19-aug-2021, (b)(4).Heartware ventricular assist system ¿ battery model #: 1650de/ catalog #: 1650de/ expiration date: 31-oct-2022 / serial #: (b)(4), udi #: (b)(4).Device evaluation anticipated, but not yet begun mfg date: 28-oct-2021.Patient ime codes: (b)(4).Heartware ventricular assist system ¿ battery model #: 1650de/ catalog #: 1650de/ expiration date: 30-nov-2022 / serial #: (b)(4), udi #: (b)(4).Device evaluation anticipated, but not yet begun mfg date: 30-nov-2021 patient ime code(s): (b)(4).Heartware ventricular assist system ¿ battery model #: 1650de/ catalog #: 1650de/ expiration date: 31-jan-2023, serial #:(b)(4), udi #:(b)(4).Device evaluation anticipated, but not yet begun, mfg date: 07-jan-2022, (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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the batteries exhibited power switching and it was noted that regular ventricular assist device (vad) disconnections occurred.It was also reported that the controller exhibited loss of power and the ports on the controller looked dirty.The controller and batteries were replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for device analysis and investigation completion.Product event summary: one (1) controller ((b)(6)) and four (4) batteries ((b)(6)) were 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 devices in relation to the reported event.Failure analysis of the returned batteries revealed that the devices passed visual inspection and functional testing.Failure analysis of the returned controller revealed that the unit passed functional testing.Visual inspection revealed contamination within both power ports of the controller, likely due to the handling of the device.Supplemental testing was performed on the controller and the test results revealed that the gold-plating of the pins were worn, exposing the base metal.The exposure of the base metal is susceptible to the effects of corrosion.Log file analysis revealed that (b)(6) contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Analysis of the data log file revealed premature power switching events that were due to momentary disconnections involving (b)(6), as well as momentary disconnections that did not lead to premature power switching events involving (b)(6) within the analyzed period.In addition, review of the data log file revealed instances involving (b)(6), where the batteries¿ relative state of charge (rsoc) values were logged between 101-201, which is indicative of communication errors.Analysis of the event log file revealed six (6) controller power-up events with associated motor start events logged on 15-may-2022 at 09:23:48, on 22-may-2022 at 17:01:22, on 30-may-2022 at 20:48:47, on 01-jun-2022 at 19:21:13, on 02-jun-2022 at 22:01:07 and on 03-jun-2022 at 08:56:49.The controller was without power for 9 seconds, 8 seconds, 11 seconds, 10 seconds, 55 seconds, and 10 seconds, respectively.Momentary disconnections were recorded leading up to several losses of power.As a result, the reported events were confirmed.The associated batteries were lubricated prior to release.The most likely root cause of the reported premature power switching events can be attributed to momentary disconnections due to contamination within the power ports and/or due to temporary corrosion of the controller-port/power-source pins.A possible root cause of the losses of power 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.Possible root causes of the observed 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: battery (b)(6), h3: yes h6: img code(s): g0403401 h6: fda method code(s): b17, b15 h6: fda results code(s): c04 h6: fda conclusion code(s): d02 battery (b)(6), d9: yes, return date: 24-jun-2022 h3: yes dev rtn to mfr? yes h6: img code(s): g0403401 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: img code(s): g0403401 h6: fda method code(s): b17, b15 h6: fda results code(s): c04 h6: fda conclusion code(s): d02 battery (b)(6), d9: yes, return date: 24-jun-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: 24-jun-2022 h3: yes dev rtn to mfr? yes h6: img code(s): g0403401 h6: fda method code(s): b01, b15 h6: fda results code(s): c04 h6: fda conclusion code(s): d02 battery (b)(6), d9: yes, return date: 24-jun-2022 h3: yes dev rtn to mfr? yes h6: img code(s): g0403401 h6: fda method code(s): b01, b15 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 - 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: 14594637
• MDR Text Key: 301731448
• Report Number: 3007042319-2022-05315
• 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
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2019
• 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: 1104 VAD
• Patient Sex: Female