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

Catalog Number 1407IT

Device Problems Loose or Intermittent Connection (1371); Device Handling Problem (3265)

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

Event Date 01/30/2016

Event Type  malfunction  

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.The reported event "power disconnect" alarm was confirmed.  analysis of the device confirmed that the controller was unable to communicate with the external batteries because the voltage induced transient events protector array and the quadruple fet bus switch were damaged.This condition might have also caused the "critical battery" alarm observed after the controller had  been replaced.  despite this condition, the controller continued to power the pump from both ports; although there was an intermittent connection on port 2.This damage was most likely caused by the improper handling of the connection of the ac adapter (forced connection and twisting of the ac adapter connector) to the controller's power port 2 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.Driveline site infection/tissue errosion/tissue damage is/are a known potential adverse event associated with the use of all vads as outlined in the instructions for use (ifu).The ifu and patient manual addresse guidelines for optimal patient management including pre and post-operative infection control measures and driveline care.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 that the patient was in the first aid station for chest pain.The controller began to alarm "power disconnect", even if it was connected to a charged battery and/or the ac adapter.There was no pump stoppage at any time.After the controller was exchanged, two charged batteries and the controller unit began to alarm "critical battery." the controller unit kept turning off and on, so log files could not be downloaded.

Manufacturer Narrative

(b)(4) was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Log file analysis revealed multiple critical battery alarms logged with an incorrect data stamp and no battery capacity, id, or cycle count.Internal inspection of the controller revealed a damaged diode on the communication line pertaining to power port 2.Additionally, it was observed that the integrated circuit responsible for the communication between the controller and batteries was damaged.As a result, the controller was unable to determine the capacity of the battery, causing the controller to trigger a critical battery alarm.  analysis of (b)(4) revealed that the device failed functional testing as it was unable to communicate with external batteries on power port 2 and registered critical battery alarms.The controller would still accept power from a controller ac adapter.Log files analysis confirmed the occurrence of multiple critical battery alarms taking place sometime after 08:37:42 hours on (b)(6) 2016.  after that, the controller lost its internal clock capabilities, capturing the time and date in a frozen state (0:00:00 - 02/31/2099).  these readings are consistent with the device analysis findings.A possible root cause for the damaged diode and integrated circuit on the communication line can be attributed to a misalignment of the cac adapter on power port 2 of the controller, causing a voltage spike on the communication pin of the connector.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: natalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 6034279
• MDR Text Key: 57689452
• Report Number: 3007042319-2016-03628
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• 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: 1407IT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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
• Patient Age: 65 YR
• Patient Weight: 68