• 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/DRIVELINE VENTRICULAR (ASSISST) 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/DRIVELINE VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 1103
Device Problems Electrical /Electronic Property Problem (1198); Failure to Pump (1502); Pumping Stopped (1503); Connection Problem (2900); Pumping Problem (3016)
Patient Problems Confusion/ Disorientation (2553); No Known Impact Or Consequence To Patient (2692); Thrombosis/Thrombus (4440)
Event Date 03/08/2020
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: heartware ventricular assist system  controller 2,0: model #: 1420 / expiration date: 21-dec-2019 / serial or lot#: (b)(4). Udi #: (b)(4). Device evaluated: no, device evaluation anticipated, but not yet begun. Mfg date: 10-dec-2018. Labeled for single use: no. Patient code(s): (b)(4). Device code(s): (b)(4). Heartware ventricular assist system  controller 2,0: model #: 1420 / expiration date: 31-may-2020 / serial or lot#: (b)(4). Udi #: (b)(4). Device evaluated: no, device evaluation anticipated, but not yet begun. Mfg date: 08-may-2019. Labeled for single use: no. Patient code(s): (b)(4). Device code(s): (b)(4). Heartware ventricular assist system  battery. Model #: 1650de / expiration date: 31-jan-2020 / serial or lot#: (b)(4) udi #:(b)(4). Device evaluated: no, device evaluation anticipated, but not yet begun. Mfg date: 14-jan-2019. No. Patient code(s): (b)(4). Device code(s): (b)(4). Heartware ventricular assist system  battery. Model #: 1650de / expiration date: 30-nov-2019 / serial or lot#: (b)(4) udi #: (b)(4). Device evaluated: no, device evaluation anticipated, but not yet begun. Mfg date: 12-nov-2018. Labeled for single use: no. Patient code(s): (b)(4). Device code(s): (b)(4). Heartware ventricular assist system  battery. Model #: 1650de / expiration date: 31-oct-2019 / serial or lot#: (b)(4) udi #: (b)(4). Device evaluated:no, device evaluation anticipated, but not yet begun. Mfg date: 11-oct-2018. Labeled for single use: no. Patient code(s):(b)(4). Device code(s): (b)(4). Heartware ventricular assist system  battery. Model #: 1650de / expiration date: 30-nov-2019 / serial or lot#: (b)(4). Udi #: (b)(4). Device evaluated: no, device evaluation anticipated, but not yet begun. Mfg date: 20-nov-2018. Labeled for single use: no. Patient code(s): (b)(4). Device code(s): (b)(4). Heartware ventricular assist system  battery. Model #: 1650de / expiration date: 31-jan-2020 / serial or lot#: (b)(4). Udi #: (b)(4). Device evaluated: no, device evaluation anticipated, but not yet begun. Mfg date: 14-jan-2019 labeled for single use: no. Patient code(s): (b)(4). Device code(s): (b)(4). Heartware ventricular assist system  battery. Model #: 1650de / expiration date: 30-nov-2019 / serial or lot#: (b)(4). Udi #: (b)(4). Device evaluated: no, device evaluation anticipated, but not yet begun. Mfg date: 19-nov-2018. Labeled for single use: no. Patient code(s): (b)(4). Device code(s): (b)(4). Heartware ventricular assist system  battery. Model #: 1650de / expiration date: 31-jan-2020 / serial or lot#: (b)(4) udi #: (b)(4). Device evaluated: no, device evaluation anticipated, but not yet begun. Mfg date: 14-jan-2019. Labeled for single use: no. Patient code(s): (b)(4). Device code(s): (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 patient was transported to the hospital with multiple ventricular assist device (vad) stop alarms from the primary and back up controller. This occurred with batteries and with multiple power sources connected. The patient has a history of double disconnects and driveline disconnects. The patient is often confused about changing power sources. According to log file report, there were double power disconnects with subsequent motor starts and controller exchanges resulting in the vads inability to restart. The vad was turned off and the outflow graft was ligated at the aorta. The vad was exchanged. The batteries and controllers remain 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/DRIVELINE
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 Key9900740
MDR Text Key240129745
Report Number3007042319-2020-02758
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00888707003261
UDI-Public00888707003261
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,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
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 Received07/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2018
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: 03/30/2020 Patient Sequence Number: 1
-
-