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U.S. Department of Health and Human Services

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

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 1103
Device Problems Disconnection (1171); Increase in Suction (1604); Power Problem (3010); Pumping Problem (3016)
Patient Problems Cardiac Arrest (1762); Tachycardia (2095); Ventricular Fibrillation (2130); Heart Failure/Congestive Heart Failure (4446)
Event Date 04/30/2021
Event Type  Injury  
Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion. Additional products: heartware ventricular assist system  controller 2. 0 model #: 1420 / catalog #: 1420 / expiration date: 30-jun-2021 / serial or lot#: (b)(4), udi #: (b)(4) device evaluated: no. No, device evaluation anticipated, but not yet begun mfg date: 30-jun-2020. 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 found unresponsive by floor staff while the controller exhibited low flow alarms as well as a no power alarm. It was noted that no power sources were connected to the controller. Power was immediately re-connected and the patient was given cardiopulmonary resuscitation (cpr). The patient then needed to be resuscitated, intubated, and moved to the cardiothoracic intensive care unit (cticu). The patient was then started on inhaled nitric oxide and multiple inotrope drips, and the ventricular assist device (vad) speed was decreased due to suction. The patient coded again and echocardiogram showed very dilated right ventricle (rv) indicating worsening right heart failure. Upon telemetry review, patient was in slow ventricular tachycardia (vt) that lead to ventricular fibrillation (vf) around the time of the controller double disconnect and loss of power. The vad and controller remain 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 (ASSISST) 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 Key11779365
MDR Text Key260438539
Report Number3007042319-2021-03499
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 Physician Assistant
Type of Report Initial,Followup
Report Date 07/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2015
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 Received07/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2013
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: 05/05/2021 Patient Sequence Number: 1
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