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

Model Number 1440

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

Patient Problem Dizziness (2194)

Event Date 02/19/2018

Event Type  malfunction  

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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the controller dc adapter provided intermittent electrical connection while plugged in, with the plug light indicator flashing intermittently.While the controller dc adapter was in-use, the patient also disconnected a low-power battery and was preparing to connect a fully-charged battery, but the pump had a loss of external power and stopped, at which time the patient experienced dizziness and lightheadedness.The symptoms resolved as soon as a fully-charged battery was connected to the controller and the pump re-started.The controller dc adapter was exchanged.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the controller dc adapter passed visual inspection and passed functional testing.No anomalies of any type were observed during in-house testing.The reported event was not confirmed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The controller dc adapter was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Failure analysis of the returned device revealed that the device passed visual examination and functional testing.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 data files revealed momentary disconnections involving an adapter.The controller log files cannot distinguish between a controller ac and dc adapter since the serial number of adapters are not recorded in the log files.As a result, it's possible the reported "plug light indicator flashing intermittently" event was confirmed.Additionally, analysis of the event files revealed that the controller had a power up event on (b)(6) 2018 at 10:50:52.The event files revealed that the loss of power occurred at 10:50:24.As a result, the loss of power was for 28 seconds.The data point prior the loss of power revealed that a battery with 94% rsoc was connected on power port one (1) and a battery was connected to power port (2) with 24% rsoc.The data point after the loss of power revealed that no power source was connected on power port 1 and a battery with 97% rsoc was connected on power port 2.The reported loss of power was confirmed; however, there is no evidence that indicated that the dc adapter was connected during the loss of power.A possible root cause of the loss of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.A possible root cause for the "plug light indicator flashing intermittently" event can be attributed to a momentary disconnection between the controller and dc adapter.Capa00350 investigated momentary disconnections.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: a5; h6.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.

Manufacturer Narrative

Product event summary: based on the log file analysis, the loss of power may have occurred due to a double disconnection of both power sources, given that both power sources connected prior to the loss of power were replaced.The controller dc adapter was not involved in controller power up event.Investigation is ongoing.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 DC ADAPTER
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7316354
• MDR Text Key: 102082292
• Report Number: 3007042319-2018-00935
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000260
• UDI-Public: 00888707000260
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/10/2018

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 Model Number: 1440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 03/16/2018; 04/13/2018; 07/13/2018; 08/08/2018; 10/09/2018
• Supplement Dates FDA Received: 04/10/2018; 05/11/2018; 07/31/2018; 10/03/2018; 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1903-2018
• Patient Sequence Number: 1
• Treatment: (B)(4).
• Patient Age: 71 YR
• Patient Weight: 66