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

Catalog Number 1407DE

Device Problem Image Display Error/Artifact (1304)

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

Event Date 03/11/2016

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) provides instructions for properly connecting the power sources.It instructs to line up the solid white arrow on the connector with the white dot.Gently push the cable into the controller.Do not twist the connector, but allow it to naturally lock in place.A successful connection will result in an audible click.The ifu cautions, "do not force connectors together without proper alignment.Forcing together misaligned connectors may damage the connectors." if both power sources are disconnected from the controller, a loud, continuous alarm will sound and there will be no message on the controller display.The pump is not pumping and power sources should be connected immediately.If this action does not resolve the alarm condition replace the controller." 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 from the site that during smr-upgrade the controller failed the preliminary test procedure step 1.2, where the power source 2 indicator does not light.It was stated that there were no effect on the patient and was doing fine the whole time.No additional information available.

Manufacturer Narrative

After review of additional information received device available for evaluation?, mfr info, date received by mfr, type of reports, if follow-up, what type?, device manufacture date and evaluation codes have been updated accordingly.The hvad is used for treatment not diagnosis.It was reported that the indicator pertaining to power port two (2) was faulty.The controller, (b)(4), was not returned for evaluation.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.The reported event could not be confirmed as the unit was not returned for analysis.Corrected data: expiration date.

• 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: 5542236
• MDR Text Key: 41691530
• Report Number: 3007042319-2016-01469
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2016

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
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: 1407DE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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