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U.S. Department of Health and Human Services

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

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HEARTWARE, INC HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER CIRCULATORY ASSIST SYSTEM, Back to Search Results
Catalog Number 1403US
Device Problems Failure to Pump (1502); Pumping Stopped (1503)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/06/2017
Event Type  malfunction  
Manufacturer Narrative
Date mfr received for initial report is 2017-09-06. This event was assessed and is being reported as part of a retrospective review of log file data. If information is provided in the future, a supplemental report will be issued.
 
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. Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.
 
Event Description
It was reported that the controller alarmed for a ventricular assist device (vad) stop while the patient was in the hospital.   the controller was exchanged.   no patient complications have been reported as a result of this event.    .
 
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER
Type of DeviceCIRCULATORY 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
anne schilling
8200 coral sea street ne
mounds view, MN 55112-3105
7635052036
MDR Report Key6914959
MDR Text Key267962331
Report Number3007042319-2017-03542
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 10/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2018
Device Catalogue Number1403US
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/04/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0005-2017, Z-1538-2017

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