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); Device Contamination with Chemical or Other Material (2944); Power Problem (3010)

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

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: brand name: heartware ventricular assist system ¿ controller 2.0, model #: 1420, catalog #: 1420, expiration date: (b)(6) 2020, serial or lot#: (b)(4), udi #: (b)(4).Device available for evaluation: yes.Return date: 02-jun-2021.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Dev rtn to mfr? yes.Mfg date: 18-jun-2019.Labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿battery, model #: 1650, catalog #: 1650, expiration date: 30-sep-2020 , serial or lot#: (b)(4) udi #: (b)(4), device available for evaluation:yes.Return date: 02-jun-2021.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Dev rtn to mfr? yes.Mfg date: 19-sep-2019.Labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿battery, model #: 1650, catalog #: 1650, expiration date: 30-sep-2020, serial or lot#: (b)(4), udi #: (b)(4).Device available for evalution: yes, return date: 02-jun-2021.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Dev rtn to mfr? yes.Mfg date: 26-sep-2019.Labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿battery, model #: 1650, catalog #: 1650, expiration date: 30-sep-2020, serial or lot#: (b)(4), udi #: (b)(4).Device available for evalution:yes.Return date: 02-jun-2021.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Dev rtn to mfr? yes.Mfg date: 30-sep-2019.Labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿battery, model #: 1650, catalog #: 1650, expiration date: 30-sep-2020, serial or lot#: (b)(4), udi #: (b)(4), device available for evaluation: yes.Return date: 02-jun-2021.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Dev rtn to mfr? yes.Mfg date: 14-sep-2019.Labeled for single use: no.(b)(4).Heartware ventricular assist system ¿battery, model #: 1650, catalog #: 1650, expiration date: 30-sep-2020, serial or lot#: (b)(4), udi #: (b)(4).Device available for evaluation: yes.Return date: 02-jun-2021.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Dev rtn to mfr? yes.Mfg date: 30-sep-2019.Labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿battery, model #: 1650, catalog #: 1650, expiration date: 30-sep-2020, serial or lot#: (b)(4), udi #: (b)(4).Device available for evaluation:yes.Return date: 02-jun-2021.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Dev rtn to mfr? yes.Mfg date: 29-sep-2019.Labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿controller ac adapter, model #: 1430, catalog #: 1430, expiration date: 30-sep-2021, serial or lot#: (b)(4), udi #: (b)(4), device available for evalutoin: yes.Return date: 02-jun-2021.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Dev rtn to mfr? yes.Mfg date: 30-sep-2020.Labeled for single: no.(b)(4).

Event Description

It was reported that two controllers, six batteries, and one controller ac (cac) adapter were suspected of power switching and there was random intermittent beeping with no particular power source.It was further reported that the power ports on the controllers were contaminated with foreign material.The controllers, batteries, and cac adapter were exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation.Product event summary: two controllers, six batteries, and one controller ac adapter were 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 and controller ac adapter revealed that the devices passed visual inspection and functional testing.Failure analysis of (b)(6) revealed that the controller passed visual inspection and functional testing.No contamination was observed within the controller ports.Failure analysis of (b)(6) revealed that the device passed functional testing.Visual inspection of (b)(6) revealed contamination within both power ports of the controller.Supplemental testing was performed on the controller (b)(6) 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 pertaining to (b)(6) revealed that the controller was not in use during the reported event and was likely the patient's back up controller.Log file analysis revealed that the controller in use during the reported event, (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 several premature power switching events that were due to momentary disconnections involving (b)(6), and a controller adapter.Analysis of the data log files also revealed several momentary disconnections that did not lead to premature power switching events involving (b)(6).Momentary disconnections will result in an audible tone or 'beep'.As a result, the reported premature power switching event, beeping event, and reported power port contamination event involving (b)(6) were confirmed.The reported power port contamination event involving (b)(6) was not confirmed.The associated power sources were lubricated prior to release.The most likely root cause of the reported premature power switching and beeping events can be attributed to momentary disconnections due to con tamination within the power ports and/or due to temporary corrosion of the controller-port/power-source pins.A possible root cause of the reported power port contamination event involving (b)(6) can be attributed but not limited to the handling of the device.Additional products: d4: model #: serial or lot#: (b)(6) h3: yes h6: fda method code(s): b01, b15 h6: fda results code(s): c04, c06 h6: fda conclusion code(s): d02, d11 d4: model #: serial or lot#: (b)(6) h3: yes h6: fda method code(s): b01, b15 h6: fda results code(s): c04 h6: fda conclusion code(s): d02 d4: model #: serial or lot#: (b)(6) h3: yes h6: fda method code(s): b01, b15 h6: fda results code(s): c04 h6: fda conclusion code(s): d02 d4: model #: serial or lot#: (b)(6) h3: yes h6: fda method code(s): b01, b15 h6: fda results code(s): c04 h6: fda conclusion code(s): d02 d4: model #: serial or lot#: (b)(6) h3: yes h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d4: model #: serial or lot#: (b)(6) h3: yes h6: fda method code(s): b01, b15 h6: fda results code(s): c04 h6: fda conclusion code(s): d02 d4: model #: serial or lot#: (b)(6)h3: yes h6: fda method code(s): b01, b15 h6: fda results code(s): c04 h6: fda conclusion code(s): d02 d4: model #: serial or lot#: (b)(6) h3: yes 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
• MDR Report Key: 11939324
• MDR Text Key: 273811047
• Report Number: 3007042319-2021-03833
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707006859
• UDI-Public: 00888707006859
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2020
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Manufacturer Received: 05/24/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1103 VAD
• Patient Age: 68 YR