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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 Power Up (1476); Failure to Pump (1502); Device Displays Incorrect Message (2591); Material Integrity Problem (2978); Pumping Problem (3016); Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2018
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. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient experienced a high watt alarm immediately followed by an electrical fault alarm. They were admitted to the hospital and the high watt alarm cleared, but the electrical fault remained. There was no physical visible damage to the driveline or the driveline connection. The driveline connector was manipulated, pushed into the controller, and moved from side to side and the alarm did not clear. Overnight the patient continued to have an electrical fault alarm and a cleaning procedure was recommended. The patient was given medication in anticipation of pump stops. The cleaning procedure was attempted, and the driveline was reconnected to a different controller, however the pump did not restart. The cleaning was attempted again, and the pump did not restart. Multiple attempts at cleaning the internal driveline pins and switching out of multiple controllers did not work. After approximately twenty minutes of this, it was decided to perform a pump exchange. During the pump exchange, it was noted that there was a tear in the silicone strain relief at the junction of driveline and pump housing. The tear can be seen on the pump. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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
MDR Report Key7669278
MDR Text Key113395930
Report Number3007042319-2018-02877
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00888707000017
UDI-Public00888707000017
Combination Product (y/n)N
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
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 Received07/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-0946-2021

Patient Treatment Data
Date Received: 07/09/2018 Patient Sequence Number: 1
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