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

Catalog Number 1403US

Device Problems Image Display Error/Artifact (1304); Connection Problem (2900)

Patient Problem Anxiety (2328)

Event Date 07/20/2016

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 and patient manual 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 damage.Additionally, a reference guide for both visual and tone alarms including potential causes and actions to take and there is a warning to keep spare, fully charged batteries and back up controller available at all times.It also provides information about proper care of the system and what to do in case of an emergency.Always wait until the "ready" turns on to disconnect the battery from the battery charger.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 by that while she was at home, she was going to switch her power sources from battery to ac.When she looked down at the controller, she noted having 2 or 3 bars on one battery gauge and 3 on the other.Suddenly she states that she could not see any information on the screen of the controller.She then noticed that it appeared her driveline was disconnected.She reached down and pushed it back in, but after discussion with the site, she thinks it may just have been the driveline cover that was out of place.Patient states not having any alarms during the process and after she moved the cover, everything looked normal again on the controller.Site brought her in.Per log file analysis, no alarms, pump stops or power disconnects were noted during the time of events.Patient was noted to have a sub-therapeutic inr upon admission as well so patient went to the pharmacy to obtain and inject lovenox prior to the site doing the controller exchange.No consequence to patient.No additional information available.

Manufacturer Narrative

The reported event of a faulty display could not be confirmed on the returned controller, con100571.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Log file analysis did not reveal any anomalies during the analyzed period.Analysis revealed that the device passed visual examination and functional testing.The liquid crystal display (lcd) performed as expected.Additionally, the leds were all functional.As a result, the reported event could not be confirmed; the device passed visual and functional testing.No failure detected, the reported event could not be duplicated at the bench level.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: 6089065
• MDR Text Key: 59727324
• Report Number: 3007042319-2016-04035
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000116
• UDI-Public: 010088870700011611150521
• 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
• Type of Report: Initial,Followup
• Report Date: 07/21/2016

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: 05/31/2016
• Device Catalogue Number: 1403US
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2015
• 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