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

Device Problem Image Display Error/Artifact (1304)

Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)

Event Date 05/06/2016

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 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.The instructions for use (ifu) and patient manual include a reference guide for both visual and tone alarms including potential causes and actions to take.  additionally there is a warning to keep spare, fully charged batteries and back up controller available at all time.The steps for exchange of batteries and controllers are outlined.  heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Event Description

It was reported that during clinic visit this patient complained of the primary controller lcd screen not working.ࠔhe controller was exchanged was without issue and the patient was provided a new back up controller.ࠎo further information was provided.

Manufacturer Narrative

After further review of additional information received sections have been updated accordingly.Correction: the reported event of a display error on a patient's controller could not be confirmed as the controller's product id is unknown.Review of the manufacturing documentation could not be performed since the device's product id is unknown.Log file analysis was not conducted since the devices product id is unknown.Analysis of the device could not be performed since the device was not returned for evaluation.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• 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: nathalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 5708420
• MDR Text Key: 46862581
• Report Number: 3007042319-2016-02138
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 06/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 70