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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); Noise, Audible (3273)
Patient Problem Thrombus (2101)
Event Date 03/27/2020
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, medical device: model #: 1420 / catalog #: 1420 / expiration date: 31-dec-2018 / serial or lot#: (b)(4), udi #: (b)(4), device available for evaluation? no. Device evaluated by manufacturer? no, device evaluation anticipated, but not yet begun. Device mfg date: 04-dec-2017. Labeled for single use? no. (b)(4). Investigation of this event is pending and a supplemental report will be sent upon its completion. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the controller exhibited an unexpected loss of power. There was also a ventricular assist device (vad) stop alarm which led to an exchange of the controller. After the controller exchange, the vad would not restart and a grinding noise was heard. Pump speed would not go above 800 revolutions per minute. A second controller exchange was attempted and pump would still not restart. Thrombus was suspected to be causing the vad stop and inability to restart. It was further reported that the patient was stable with the vad off and was on inotropes until a transplant was available. The vad was therefore removed from service when the patient received a transplant. 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 Key9937949
MDR Text Key196600207
Report Number3007042319-2020-02828
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00888707002639
UDI-Public00888707002639
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
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
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 Received02/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2018
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: 04/08/2020 Patient Sequence Number: 1
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