MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE EXTENSION CABLE; VENTRICULAR (ASSIST) BYPASS

Model Number	100US
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional 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: one (1) driveline extension cable was not returned for evaluation.A review of the manufacturing documentation confirmed that the associated device met all requirements for release.Per the manufacturing documentation, the expiration date for the driveline extension cables is 31/oct/2019.Visual evidence provided by the site revealed a packaging label with an incorrect expiration date.As a result, the reported event was confirmed.Based on the available information, the most likely root cause of the reported event can be attributed to improper labeling during packaging.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The driveline extension cable was returned due to the expiration date on the packaging being two months prior than the actual expiration date.The driveline extension cable subsequently tested out of specification during manufacturer¿s analysis.There was no patient involvement.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE EXTENSION CABLE
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8684061
• Report Number: 3007042319-2019-07246
• Device Sequence Number: 11288568
• Product Code: DSQ
• UDI-Device Identifier: 00888707000024
• UDI-Public: 00888707000024
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 100US
• Device Catalogue Number: 100US
• Device Lot Number: D000041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1