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

Catalog Number 1407DE

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2016

Event Type  malfunction  

Manufacturer Narrative

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.Per the instructions for use (ifu): patients are instructed to always keep a back-up controller available at all times, beyond the primary controller that is currently in use.Patients are instructed to contact the treating facility if they receive any of a list of certain alarms.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.Product is in route.

Event Description

It was reported that during the software maintenance release (smr) upgrade the medical staff noted a loose power port connector.The controller was exchanged with no reported effect on the patient.No further information was provided.

Manufacturer Narrative

The hvad is used for treatment not diagnosis.One 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.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.The reported event was confirmed via visual inspection.Analysis of the device revealed that the device failed to meet specifications; the device failed visual inspection due to the power port one (1) connector was found loose from controller housing with the o-ring gasket displaced and locknut loose inside the controller's housing.The supplier had an open internal investigation for the controller's loose connectors.A possible root cause of the loose connectors may be attributed to a shift in the manufacturing process.The instructions for use and patient manual outline the steps for handling and properly connecting power sources, including ensuring proper alignment, as well as instructions not to twist or force connections together in order to prevent damage.Additionally, a reference guide for both visual and tone alarms including potential causes and actions to take and there is a warning to keep spare, fully charged batteries and back up controller available at all times.It also provides information about proper care of the system and what to do in case of an emergency.Always wait until the "ready" turns on to disconnect the battery from the battery charger.Labeled for single use.

• 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: nathalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 5699494
• MDR Text Key: 46565673
• Report Number: 3007042319-2016-02098
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 1407DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FSCA APR2016
• Patient Sequence Number: 1