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

Catalog Number	1650
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported power consumption issue with the returned battery was not confirmed.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.The reported event could not be confirmed via review of the controller log files since log analysis revealed the battery was able to hold charge for over four hours.Analysis of the device revealed that the device met specifications; the device passed visual examination and functional testing.The reported power consumption issue could not be duplicated at the bench level; the device performed as intended.However, there is a potential for this battery to malfunction due to faulty lishen cells within the hvad battery pack.This potential malfunction could have contributed to the reported event.Heartware has opened internal investigations under to evaluate lishen batteries with faulty cell pairs.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.The heartware system instructions for use (ifu), patient manual, and training material provide clear instructions to the user on proper usage and care of hvad power sources.Moreover, the ifu provides instruction to further educate the patient about product safety, alarm management, and device management; additional guidelines instruct the user on how to detect and react to a power source malfunction.Heartware is submitting this correction to a previously submitted mdr report as a result of remediation activities related to fda warning letter fla-14-14, dated june 2, 2014, and pursuant to the provisions of 21 cfr part 803.
Event or Problem Description
It was reported from the us that during a clinic visit, the patient reported that one of his batteries only holds charge for 1 hour.No reported consequences or impact to patient.The hospital replaced the battery and no additional information provided.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM
• Common Device Name: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• MDR Report Key: 6087098
• Report Number: 3007042319-2016-03887
• Device Sequence Number: 11169344
• Product Code: DSQ
• UDI-Device Identifier: 00888707000079
• UDI-Public: (01)00888707000079(11)141027(21)
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,study
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/09/2015

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: 10/31/2015
• Device Catalogue Number: 1650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2015
• Initial Report FDA Received Date: 11/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1887-2016
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 104