• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 1104
Device Problems Electrical /Electronic Property Problem (1198); Failure to Pump (1502); Pumping Stopped (1503)
Patient Problem Heart Failure (2206)
Event Date 07/04/2020
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 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. Additional products: brand name: heartware ventricular assist system ¿ controller 2. 0. Model #: 1420, catalog #: 1420, expiration date: 31-aug-2019, serial #: (b)(4), udi #: (b)(4). Device available for evaluation: no. Device evaluated by mfr: no, device evaluation anticipated, but not yet begun. Mfg date: 06-aug-2018. 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 ventricular assist device (vad) stopped and was unable to be restarted. It was reported that there was suspected electrical damage and a review of data log files showed an apparent double power disconnection from the controller. The patient experienced worsening heart failure and was admitted to the intensive care unit (icu) and required administration of adrenaline. The vad remains out of service and the controller remains in use. No further patient complications have been reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10255633
MDR Text Key205360575
Report Number3007042319-2020-04864
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
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 Received02/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2018
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: 07/09/2020 Patient Sequence Number: 1
-
-