MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM -CONTROLLER; CIRCULATORY ASSIST SYSTEM,

Catalog Number 1403US

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2017

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.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Event Description

It was observed that the controller had a date and time error that caused the year to display incorrectly.The controller was upgraded.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Correction/removal number: z-1731-2015.The returned controller failed visual inspection and functional testing.Visual inspection failed as a result of a loose ps1 connector.System testing did not indicate any abnormal operation of the controller, except that their real time clock (rtc) was reset to zero.However, when the date and time were set to actual time and the internal battery (bt2) was adequately recharged, controller was able to keep accurate date and time.As an incidental finding it was observed that the internal battery bt1 in the power board was found lightly corroded.The customer complaint that "it was observed that the controller had a date and time error that caused the year to display incorrectly" was confirmed.An internal investigation has been opened by the supplier to address loose connectors.An internal investigation has been opened to address internal controller alarm battery failure.The rtc was reset to zero most likely because controller had not been connected to external power for an extended period of time.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.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM -CONTROLLER
• Type of Device: CIRCULATORY ASSIST SYSTEM,
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer (Section G): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer Contact: anne schilling ; 8200 coral sea street ne; mounds view, MN 55112-3105 ; 7635052036
• MDR Report Key: 6990088
• MDR Text Key: 91213187
• Report Number: 3007042319-2017-03859
• Device Sequence Number: 1
• Product Code: DSQ
• 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: health professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 1403US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0005-2017, Z-1538-2017
• Patient Sequence Number: 1
• Patient Age: 52 YR