• 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 (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 VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 1103
Device Problems Increase in Suction (1604); Vibration (1674)
Patient Problems Stroke/CVA (1770); Fall (1848); Syncope/Fainting (4411)
Event Date 05/24/2022
Event Type  Injury  
Event Description
It was reported that the patient had a syncopal episode where the patient fell and did not hit their head. The patient went to the emergency room where the patient and provider reported palpable vibrations over the left nipple line from the ventricular assist device (vad). The provider noted that the vad sounded turbulent. The sounds were continuous and not intermittent during times of suction. Logfile review noted suction alarms. A computerized tomography (ct) head/brain scan was performed and revealed multiple infarcts that were chronic in multiple territories of the brain. No further interventions were taken. The vad remains in use. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion. Additional information has been requested regarding additional event details, but it was not available at the time of this report. If additional information is received, the event will be updated and a supplemental report will be sent. If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key14691519
MDR Text Key294013390
Report Number3007042319-2022-05411
Device Sequence Number1
Product Code DSQ
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2015
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2013
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: 06/15/2022 Patient Sequence Number: 1
-
-