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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE LVAS VENTRICULAR (ASSIST) BYPASS

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HEARTWARE, INC. HEARTWARE LVAS VENTRICULAR (ASSIST) BYPASS Back to Search Results
Device Problems Inappropriate Waveform (2536); Protective Measures Problem (3015); Appropriate Term/Code Not Available (3191)
Patient Problems Bacterial Infection (1735); Respiratory Failure (2484)
Event Date 02/05/2018
Event Type  Injury  
Event Description
Heartware patient presents with high watt alarm, hemoglobinuria, abnormal left ventricular assist device (lvad) waveforms in the setting of international normalized ratio (inr) 2. 4 and aspirin 325 mg daily. Lactic acid dehydrogenase (ldh) peaked at 4692, and plasma hemoglobin 156. Patient required heartware to heartware exchange on day 2; post op complications included respiratory failure requiring trach and bacteremia. Heparin to coumadin bridge was completed prior to discharge and aspirin 325 was resumed.
 
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Brand NameHEARTWARE LVAS
Type of DeviceVENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
HEARTWARE, INC.
14400 nw 60th ave
miami lakes FL 33014
MDR Report Key10017036
MDR Text Key189590669
Report Number10017036
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/28/2020
Device Age3 YR
Event Location Home
Date Report to Manufacturer05/01/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/01/2020 Patient Sequence Number: 1
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