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

Catalog Number 1403US

Device Problems Image Display Error/Artifact (1304); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2016

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.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.It further warns that damaged equipment should be reported to the manufacturer and inspected.When one battery is depleted to <25%, the controller will automatically switch to the other battery.When this happens, an intermittent "beep" will sound, the alarm indicator on the controller will be yellow, and a message will be displayed to replace the depleted battery.If the battery is not changed within 5 minutes, the alarm volume will escalate until the battery is exchanged with a fully charged battery.When a depleted battery is not exchanged and there are only a few minutes of battery time remaining in both batteries, a high priority alarm will sound, the alarm indicator will flash red and the message on the controller will display "critical battery 1" or "critical battery 2." if this occurs, there are only a few minutes of power remaining before the pump stops; therefore, the batteries must be replaced immediately.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.The devices have been received and are awaiting further evaluation.Serial #: (b)(4) catalog #: 1650 mfg.Date: 01/31/2016 exp.Date: 01/31/2017.(b)(4).

Event Description

Per (b)(6), perfusionist, pt reported a critical battery alarm last evening.Pt replaced switched out batteries and the alarm resolved.Log files sent in today in clinic.Site also noticed that the lcd display was faint and the operating parameters were hard to read.

Manufacturer Narrative

The controller and the battery were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.The reported event was confirmed via review of the controller log files, which revealed a critical battery alarm involving battery ((b)(4)).In this instance, the battery went from a high relative state of charge (rsoc) to 0% rsoc.This observation is indicative of a communication error between the controller and battery.The manufacturer has opened an internal investigation for communication errors.Analysis of the battery and the controller revealed that the devices passed visual examination and functional testing.The reported lcd issues could not be confirmed during testing; the controller's display worked as extend, displaying all characters properly.Of note, the controller, (b)(4), in use during the event did not have the smr upgrade.The most likely root cause of the reported event can be attributed to a communication error between the controller and battery.The reported lcd issues could not be confirmed during testing; the controller's display worked as extend, displaying all characters properly.Heartware will submit a supplemental report when new facts arise which materially alters information submitted in a previous mdr report.Battery - (b)(4).

• 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: 6070910
• MDR Text Key: 58929278
• Report Number: 3007042319-2016-03943
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000116
• UDI-Public: 010088870700011611140808
• 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: Notification
• Type of Report: Initial,Followup
• Report Date: 10/05/2016

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: 08/31/2015
• Device Catalogue Number: 1403US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 11/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2014
• 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-1917-2015
• Patient Sequence Number: 1