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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSIST) BYPASS

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 1104
Device Problems Failure to Pump (1502); Pumping Stopped (1503); Pumping Problem (3016)
Patient Problems Thrombus (2101); Thrombosis/Thrombus (4440)
Event Date 03/02/2020
Event Type  Injury  
Manufacturer Narrative
This device is used for treatment not diagnosis. The ventricular assist system is indicated for use as a bridge to cardiac trans plantation 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. Additional products: brand name: heartware ventricular assist system ¿ controller 2. 0, model #: 1420 / catalog #: 1420 / expiration date: 31-aug-2018 / serial or lot#: (b)(4), udi #: asku. Device available for evaluation: no, device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun, device mfg date: 31-aug-2017, labeled for single use: no, (b)(4). Brand name: heartware ventricular assist system ¿ controller 2. 0, model #: 1420 / catalog #: 1420 / expiration date: 31-oct-2018 / serial or lot#: (b)(4), udi #: asku, device available for evaluation: no, device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun, device mfg date: 31-oct-2017, labeled for single use: no, (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient was hospitalized for low flows and computerized tomography (ct) showed a thrombus at the outflow cannula. The patient was treated for the thrombus and the ventricular assist device (vad) was temporarily turned off. When it was turned on, the vad exhibited high power and would turn itself off and back on several times. The controller was switched with another controller and the vad speed was adjusted but it did not resolve the issue. The vad remains implanted and the controllers are still in use. No further patient complications have been reported as a result of this event.
 
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Type of DeviceVENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
HEARTWARE, INC.
14400 nw 60th ave
miami lakes FL 33014
Manufacturer (Section G)
HEARTWARE, INC.
14400 nw 60th ave
miami lakes FL 33014
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key9806630
MDR Text Key196396800
Report Number3007042319-2020-01687
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model Number1104
Device Catalogue Number1104
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/31/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0946-2021

Patient Treatment Data
Date Received: 03/09/2020 Patient Sequence Number: 1
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