• 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 1104
Device Problems Electrical /Electronic Property Problem (1198); Pumping Stopped (1503); Material Integrity Problem (2978); Pumping Problem (3016); Material Split, Cut or Torn (4008)
Patient Problem Anxiety (2328)
Event Date 01/12/2022
Event Type  Injury  
Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion.
 
Event Description
It was reported that the patient accidentally cut their driveline approximately 4 centimeters (cm) from the driveline exit site during a dressing change. Review of logfiles showed that the driveline wire damage caused a momentary short in front phase a and b. There was a front-stator over-current fault followed by a rear-stator over-current 2 seconds later, and a rear-stator-only start with at least two front phases open which appeared to result in a ventricular assist device (vad) stop. There were electrical fault alarms and high watt alarms and the vad was running on single stator operation. It was also reported that the patient was very scared and anxious. Two days later the patient was taken to the operating room (or) and a successful driveline splice repair was performed. The patient was equipped with a venous access, sedated and a catheter was placed close to the outflow graft. The vad 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/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 Key13308287
MDR Text Key284130957
Report Number3007042319-2022-00231
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 Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1104
Device Catalogue Number1104
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/17/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1751-2015

Patient Treatment Data
Date Received: 01/20/2022 Patient Sequence Number: 1
-
-