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

Model Number 1403US

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2017

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.Product event summary: the controller was not returned for evaluation.A review of the manufacturing documentation confirmed that the associated device met all requirements for release.Log file analysis revealed a controller power up event on (b)(6) 2017, at 08:48:16.The data point prior to the loss of power revealed that (b)(4) was connected to power port one (1) with 97% relative state of charge (rsoc) and (b)(4) was connected to power port two (2) with 25% rsoc.The data point recorded after the loss of power revealed that (b)(4) was connected to power port (1) and (b)(4) was connected to power port two (2).The controller was without power for a maximum of 2 minutes and 9 seconds.As a result, the reported "controller loses power" event was confirmed.However, the reported "loose power connection" event could not be confirmed since the device was not available for analysis.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of loose power port connectors may be attributed to inadequate thread lock, an inconsistent thread lock cure time and an inadequate torque application during the assembly process.A possible root cause of the loss of power event can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.An internal investigation was initiated to capture events involving the controller losing power and implement corrective actions as required.This event was assessed and is being reported as part of a retrospective review of log file data.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that when exchanging the power source on one power port, the other power port became loose and the second power source was disconnected, making the controller lose power.The controller remains in use.No patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM- CONTROLLER
• 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8279170
• MDR Text Key: 135921176
• Report Number: 3007042319-2019-00434
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000116
• UDI-Public: 00888707000116
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2017
• Device Model Number: 1403US
• Device Catalogue Number: 1403US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2016
• 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
• Patient Age: 67 YR