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

Model Number 1420

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900); Power Problem (3010)

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

Event Date 01/16/2023

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#:1650/ catalog#:1650/ expiration date: 30-sep-2022, 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-sep-2021.Labeled for single use: no.Patient ime code(s): e2403.Imf code(s): f26.Img code(s): g02002.Fda device code(s): a0705.Fda method code(s): b21.Fda results code(s): c21.Fda conclusion code(s): d16.Brand name: heartware ventricular assist system ¿ battery.Model#:1650, catalog#:1650, expiration date: 30-sep-2022, 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-sep-2021.Labeled for single use: no.Patient ime code(s): e2403.Imf code(s): f26.Img code(s): g02002.Fda device code(s): a0705.Fda method code(s): b21.Fda results code(s): c21.Fda conclusion code(s): d16.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 reported that the controller and two batteries exhibited power disconnect, power switching, and intermittent loose connection.It was stated that the ¿patient experienced controller power toggle¿ in the past few days when using the batteries and fuel gauge was at 2-3 bars.It was further reported that the controller exhibited intermittent power disconnection during the patient¿s sleep at night for the last few weeks.Upon inspection, both power connections of the controller were found to be loosen.The controller and two batteries were removed from service.No patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for device analysis.Product event summary: one (1) controller (b)(6) and two (2) batteries (b)(6) were not returned for evaluation.A review of the controller's manufacturing documentation confirmed that the associated device met all requirements for release.Log file analysis revealed that the controller contains 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 several premature power switching events that were due to momentary disconnections involving (b)(6) within the analyzed period.Additionally, analysis of the data log file revealed momentary disconnections involving (b)(6) and (b)(6) that did not result in premature power switching events.Review of the alarm log file revealed no power disconnect alarms within the analyzed period.Momentary disconnections will result in an audible tone/beep.It is likely that the reported ¿power disconnect¿ event is associated with the observed momentary disconnections.The batteries had been lubricated prior to release.As a result, the reported power switching and power disconnect events were confirmed.However, the reported loose power port connectors event could not be confirmed due to insufficient evidence.Ap plicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of the reported loose power port connectors event may be attributed, but not limited, to improper assembly.The most likely root cause of the rep orted power switching/power disconnect event can be attributed to momentary disconnections between the controller and batteries.Capa pr00574181 is investigating momentary disconnections.Additional products: d4: serial or lot#: (b)(6) h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c04 h6: fda conclusion code(s): d02 d4: serial or lot#: (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 - 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: 16232935
• MDR Text Key: 309087195
• Report Number: 3007042319-2023-00204
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2020
• 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