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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSISST) BYPASS
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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSISST) BYPASS Back to Search Results
Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/19/2016
Event Type  malfunction  
Event Description
Patient with lvad therapy for 14 months presents with left ventricular assist device (lvad) alarms and a single pump stop prior to admission, in the setting of ldh peak 600, inr 3.6 on admission, and aspirin therapy.We were unable to pursue tpa treatment due to high inr on arrival.Vad completely stopped within 24 hours of arrival to hospital.Inotrope was initiated, patient was urgently listed 1a for transplant, and received successful transplant 10 days after presenting to the hospital.
 
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Brand Name
HEARTWARE VENTRICULAR ASSIST SYSTEM
Type of Device
VENTRICULAR (ASSISST) BYPASS
Manufacturer (Section D)
HEARTWARE, INC.
14400 nw 60th ave
miami lakes FL 33014
MDR Report Key6306713
MDR Text Key66679527
Report Number6306713
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/03/2017
Device Age14 MO
Event Location Home
Date Report to Manufacturer02/03/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/07/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
CARDIAC DRUGS; NO
Patient Age53 YR
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