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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 1103
Device Problems Failure to Pump (1502); Pumping Stopped (1503); Pumping Problem (3016)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/30/2018
Event Type  malfunction  
Manufacturer Narrative
This device is used for treatment not diagnosis. The ventricular assist system is indicated for use as a bridge to cardiac transplantation 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. Other devices involved in this event: heartware ventricular assist system ¿ controller 2. 0 / (b)(4)/ model #: 1420 / catalog #: 1420 / expiration date: 2018-07-31 udi #: (b)(4) return date: 2018-09-11 device evaluation anticipated, but not yet begun mfg date: 2017-07-31 (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient had an electrical fault alarm and a controller fault alarm. The site further reported that the patient had previously had a driveline repair. After performing a controller exchange, the patient was hospitalized for further interrogation. Upon further interrogation, the site observed that the driveline boot was in the right position and they could not replicate any of the alarms with the new controller. The site further noted that the patient had experienced a vad disconnect alarms, low flow alarms, as well as a vad stop alarm. After taking x-rays and doing a visual inspection there was no damage to the wires. A manufacturer representative did state that the vad stop alarm was associated with the pump unable to start on a single stator. The controller exchange was able to resolve the issue and the pump started. The controller has been exchanged and the pump remains in use. No 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
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key7886766
MDR Text Key120697103
Report Number3007042319-2018-04446
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00888707000017
UDI-Public00888707000017
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 05/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2012
Device Model Number1103
Device Catalogue Number1103
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 Received04/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/31/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/18/2018 Patient Sequence Number: 1
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