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

Catalog Number	1425US
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One cac adapter 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.Log file analysis was not conducted since functional testing revealed that the unit performed as expected.Analysis of the device revealed that the device met specifications; the device passed visual examination and functional testing.The reported event could not be confirmed as the cac adapter was able to make secure connections with and reliably provide power to the controller.Therefore the exact root cause of the reported issue could not be determined.The instructions for use (ifu) and patient manual include a reference guide for visual alarms including potential causes and actions to take.Additionally there is a warning to keep spare, fully charged batteries available at all time.The steps for exchange of batteries are outlined.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.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.
Event or Problem Description
It was reported by the vad coordinator that while the patient was seen in clinic on (b)(6) 2015, the patient mentioned that their ac adapter was not making a secure connection with the controller and that it would disconnect easily.The ac adapter was exchanged with no reported patient consequences.No further information was provided.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM - CAC ADAPTER
• Common Device Name: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• MDR Report Key: 6946498
• Report Number: 3007042319-2017-03719
• Device Sequence Number: 745283
• Product Code: DSQ
• UDI-Device Identifier: 00888707000093
• UDI-Public: 00888707000093
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2015

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: Lay User/Patient
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: 1425US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2015
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 62