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

Catalog Number 1430DE

Device Problems Device Inoperable (1663); Power Problem (3010)

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

Event Date 08/31/2016

Event Type  malfunction  

Manufacturer Narrative

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, including transportation.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.They also outline the steps for handling and properly connecting power sources, including ensuring proper alignment, as well as instructions not to twist or force connections together in order to prevent damages.It is outlined to inspect the power connections and pins once a week, one at a time when changing the power source.Additionally there is a warning to keep spare, fully charged batteries and back up controller available at all time with a warning to switch to the back-up controller if there is a controller failure the steps for exchange of devices are also outlined.It further warns that damaged equipment should be reported to the manufacturer and inspected.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.Controller has not been received.

Event Description

It was reported from the site that the controller is not getting power from the cac adapter.An elective controller exchange was performed and it was stated that there were no effect or consequences to the patient.No additional information available.

Manufacturer Narrative

Additional information was received indicating that the incorrect device (controller con191260) was reported.Cac014016 was added to the complaint.This is not likely to cause or contribute to death or serious injury.The redundant power source will continue to supply power to the pump.This failure will result in user annoyance and will not affect the function of the pump.No additional information will be forthcoming.

Manufacturer Narrative

After further review of additional information received the following sections have been updated.It was reported that the controller ac adapter was no longer providing power to a controller.The device was initially returned as a non-complaint device on (b)(6) 2016.(b)(4) was submitted into the complaint management system on (b)(6) 2016, and initially had a controller associated with the complaint.The complaint was later corrected to remove the controller and add the controller ac adapter.As a result, the device was disposed before the unit could be analyzed. review of the manufacturing documentation confirmed that the associated controller ac adapter met all requirements for release. applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of the inability of the controller ac adapter to provide power may be attributed to an open circuit along the output cable or output connector.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.This event was assessed and is being reported as part of a retrospective review of events, which was in response to an update to the mdr decision criteria.

• 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: natalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 5976773
• MDR Text Key: 55630244
• Report Number: 3007042319-2016-03355
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 1430DE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2015
• 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