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

Model Number 1475-

Device Problem Break (1069)

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

Event Date 06/24/2015

Event Type  malfunction  

Manufacturer Narrative

Product event summary: it was reported that the patient pack had a broken clip, making it unable to secure the belt.A review of the device's manufacturing records indicated there were no non-conforming material reports (ncmrs) generated that could be related to the reported event.Upon completion of the review, it was concluded that the unit met the internal requirements prior to its quality assurance release process.Evaluation of the device confirmed the reported event.The clip was broken, possibly due to abuse or mishandling of the device.This event was assessed and is being reported as part of a retrospective review of events, which was in response to an update to the mdr decision criteria.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 pack strap broke.The patient pack was replaced.No patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PATIENT PACK
• Type of Device: VENTRICULAR (ASSISST) 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7154665
• MDR Text Key: 96125300
• Report Number: 3007042319-2017-05515
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000178
• UDI-Public: 00888707000178
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1475-
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1