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

Catalog Number 1103

Device Problem Cut In Material (2454)

Patient Problem Anxiety (2328)

Event Date 05/16/2016

Event Type  Injury  

Manufacturer Narrative

This device is used for treatment not diagnosis.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.Per the instructions for use (ifu): patients are instructed to always investigate, and if possible, correct the cause of any alarm.Silencing an alarm does not resolve the alarm condition.An electrical fault is a fault in the continuity of the pump to controller electrical connection triggers this alarm.The fault could be in the hvad® pump motor, driveline and connector, or within the controller.The audio portion of this alarm can be permanently disabled via the monitor.When this alarm condition occurs, the hvad® pump will be running on a single stator and will consume slightly more power.There are no apparent clinical causes for this event.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 medical personnel that a patient came to the clinic stating he had been receiving high watt and electrical fault alarms from his controller.The vad coordinator states that visual inspection of the driveline revealed damage to the red and green wires.The patient was admitted to the hospital for a splice repair.Log files were sent confirming that the patients pump was running on one stator and that 19 low flow alarms, 6 high watt alarms, 3 vad disconnect, and 1 electrical fault had occurred, the time clock was incorrect on the controller so we are unable to tell at what time the alarms occurred.The engineers also confirmed wire damage to the red and green wires.The engineers were on site at the hospital the on the same day and a splice repair was performed.The patient tolerated the procedure well with no additional issues.No additional information provided.

Manufacturer Narrative

Additional information provided by the service report stated that the patient was prepped prior to the procedure.The rear stator was repaired without any issue and continued to the front stator.The patient's total off pump time was 20 seconds.A longer splice cable was used to abel to removed the damaged section.The controller was exchanged.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Manufacturer Narrative

Controller- (b)(4).Fda codes: method: manufacturing review (b)(4), analysis of data log(s) (b)(4), actual device not evaluated (b)(4).Results: no results available since no evaluation performed (b)(4).Conclusion: device not returned (b)(4).The pump and controller were not returned for evaluation as the devices remain with the patient.Review of the manufacturing documentation confirmed the associated devices met requirements for release.Review of the log files revealed low flow, high watt, and electrical fault alarms, confirming the reported event.The electrical fault alarm demonstrated that the patient was running on the front stator only.Onsite inspection of the driveline revealed that the green and red wires had been compromised.A splice repair was performed and the pump was able to start on both stators and all issues were resolved.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.The mostly likely root cause of the reported alarms is driveline wire damage.The most likely root cause of the reported alarms is driveline wire damage.Heartware will submit a supplemental report when new facts arise which materially alter 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 60 avenue; miami lakes FL 33014 3105
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60 avenue; miami lakes FL 33014 3105
• Manufacturer Contact: nathalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 5727020
• MDR Text Key: 47458288
• Report Number: 3007042319-2016-02196
• Device Sequence Number: 1
• Product Code: DSQ
• 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,Followup
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention