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); Power Problem (3010)

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

Event Date 04/16/2018

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 patient has been experiencing intermittent beeps on port 1 of the controller.Site stated that port 1 appears to be loose.The device has not been dropped.The user did not use excessive force when connecting to the power sources.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The controller 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 controller revealed that the unit passed functional testing.A visual inspection under 10x magnification revealed hairline cracks around power port 1 and power port 2.An internal inspection did not reveal evidence of fluid ingress.The observed hairline cracks are not related to the reported event.Based on an investigated conducted, the root cause of the hairline cracks was determined to be due to chemical additives applied to the power port gaskets during the manufacturing process.The chemical additives contributed to environmental stress cracking.The reported loose power port 1 could not be confirmed.Log file analysis revealed that the controller con311771 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 files revealed several power switching events due to momentary disconnections and communication errors involving multiple batteries.Momentary disconnection will result in an audible tone or "beep." as a result, the reported "intermittent beeping" event was confirmed.The most likely root cause of the premature power switching events can be attributed to communication errors and/or momentary disconnections between the controller and battery.However, the reported beeps are most likely attributed to momentary disconnections between the controller and battery.Momentary disconnections have been investigated by the manufacturer.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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7495409
• MDR Text Key: 107993574
• Report Number: 3007042319-2018-01798
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000420
• UDI-Public: 00888707000420
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1903-2018
• Patient Sequence Number: 1
• Patient Age: 59 YR