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U.S. Department of Health and Human Services

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

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HEARTWARE, INC HEARTWARE VENTRICULAR ASSIST SYSTEM- LVAD PUMP CIRCULATORY ASSIST SYSTEM Back to Search Results
Catalog Number 1104
Device Problem Failure to Pump (1502)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/18/2017
Event Type  malfunction  
Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: age/date of birth, other relevant history, implant date, date received by mfr, type of reports, type of reportable event, if follow up, what type?, device evaluated by manufacturer? and additonal mfr narrative. (b)(4)/catalog 1470de/expiration date: 30-apr-2013. Heartware will submit a supplemental report when new facts arise which materially alters information submitted in a previous mdr report.
 
Manufacturer Narrative
Additional devices added for this event: serial (b)(4) catalog# 1407de exp. Date: 07/31/2013, device available for evaluation?: no, not returned to manufacturer, labeled for single use?: no, (b)(4). Serial (b)(4) catalog# 1420 exp. Date: 04/30/2018, device available for evaluation?: no, not returned to manufacturer, labeled for single use?: no, (b)(4). Serial (b)(4) catalog# 1420 exp. Date: 05/31/2018, device available for evaluation?: no, not returned to manufacturer, labeled for single use?: no, (b)(4). This device is used for treatment not diagnosis. 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 during a controller exchange in the clinic the pump would not restart and the power was above 25 watts (w). The backup 2. 0 controller and the original 1. 0 controller were attempted with the same result. The pump was stopped and the speed reduced to 1800 rpm, then a controller 2. 0 was started in the pump stop mode, with speed set to 1800. The pump was connected and started in the second attempt. Speed was then set back to 2700 rpm. The patient was communicating the whole time. There were no problems after the restart of the pump. The patient was discharged home with two backup controllers. No patient complications have been reported as a result of this event.
 
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM- LVAD PUMP
Type of DeviceCIRCULATORY ASSIST SYSTEM
Manufacturer (Section D)
HEARTWARE, INC
14400 nw 60 avenue
miami lakes FL 33014 3105
Manufacturer (Section G)
HEARTWARE, INC.
14400 nw 60 avenue
miami lakes FL 33014 3105
Manufacturer Contact
nathalie nunez
14400 nw 60 avenue
miami lakes, FL 33014-3105
3053641538
MDR Report Key6786110
MDR Text Key251933620
Report Number3007042319-2017-02579
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2018
Device Catalogue Number1104
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/04/2018
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 Initial

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