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

Model Number 1407BR

Device Problems Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591)

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

Event Date 01/24/2018

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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was experiencing critical battery alarms and had a loose connector at power port 1.The loose power port was visually confirmed from a video received from the site.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The controller 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 that the device passed functional testing.Visual inspection revealed a loose power port 1 connector with the o ring gasket missing.As a result, the reported loose connector event was confirmed.Additionally, the controller power port 2 connector was observed to be tight to the controller housing with the o ring gasket displaced; this is an additional observation not related to the reported event.An internal inspection did not reveal evidence of fluid ingress.Review of the controller log files revealed that no critical battery alarms were logged in the analyzed period.Therefore, the reported critical battery alarm event could not be confirmed.The most likely root cause of the loose connector and displaced o ring gasket events 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
• MDR Report Key: 7289043
• MDR Text Key: 100895549
• Report Number: 3007042319-2018-00753
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2017
• Device Model Number: 1407BR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Date Manufacturer Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1104-HVAD