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

Model Number 1407KR

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 01/23/2016

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 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.Product event summary: the controller was returned for evaluation.A review of the manufacturing documentation confirmed that the associated controller met all requirements for release.Visual inspection of the returned controller revealed a loose power port one and power port two connector.An internal inspection did not reveal evidence of fluid ingress.Functional testing revealed that the "no power" alarm failed to sound when both power sources were disconnected.Evaluation of the internal nickel-metal hydride (nimh) battery revealed that one of the cell's voltage level was below what was expected.These are additional observations not related to the reported event.The most likely root cause for the ¿no power¿ alarm not sounding can be attributed to a faulty internal nimh battery.An internal investigation was opened to investigate "no power" audible alarm failures.Of note, the controller was manufactured 30-apr-2015.Based on an internal investigation conducted, the most likely root cause of the loose power port connectors can be attributed to inadequate thread lock, an inconsistent thread lock cure time and an inadequate torque application during the assembly process.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported suction alarm may be attributed to multiple factors including but not limited to thrombus at the inflow cannula, poor vad filling, and inappropriate pump rotational speed.If information is provided in the future, a supplemental report will be issued.

Event Description

The controller was returned to the manufacturer because of a suction event.The controller subsequently tested out of specification during manufacturer's analysis.No patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 1.0
• Type of Device: VENTRICULAR (ASSIST) 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8619313
• MDR Text Key: 145382412
• Report Number: 3007042319-2019-07009
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2016
• Device Model Number: 1407KR
• Device Catalogue Number: 1407KR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2015
• 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
• Treatment: 1104 VAD
• Patient Age: 79 YR