MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 1.0; VENTRICULAR (ASSISST) BYPASS

Model Number 1403US

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)

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

Event Date 01/02/2018

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 and destination therapy 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.

Event Description

It was reported that the controller was not able to connect to power sources due to both power ports becoming loose over time.The patient exchanged the controller.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the returned controller failed visual inspection and failed functional testing.Investigation is ongoing.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the controller, (b)(4), was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.A review of the manufacturing documentation confirmed that the associated device met all requirements for release.Failure analysis of the returned device revealed during visual inspection that the controller have loose connectors on power source 1 and power source 2.An internal inspection did not reveal evidence of fluid ingress.As a result, the reported event was confirmed.Further analysis revealed that the power port nut came in contact with the printed circuit board (pcb), causing damage to a component and integrated circuit responsible with the communication between the controller and batteries.The controller was still able to accept power, but was unable to read the relative state of charge of a battery connected to the controller.Based on an evaluation conducted under an internal investigation, the most likely root cause of the loose connector can be attributed to inadequate thread lock, an inconsistent thread lock cure time and an inadequate torque application during the assembly process.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 1.0
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7215112
• MDR Text Key: 98294987
• Report Number: 3007042319-2018-00365
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000116
• UDI-Public: 00888707000116
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• 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 Model Number: 1403US
• Device Catalogue Number: 1403US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1538-2017
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 96