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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE VENTRICULAR (ASSISST) BYPASS

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 1103
Device Problems Obstruction of Flow (2423); Pumping Problem (3016)
Patient Problems Bacterial Infection (1735); Hematuria (2558); Thrombosis/Thrombus (4440); Lactate Dehydrogenase Increased (4567)
Event Date 06/24/2022
Event Type  Injury  
Event Description
It was reported that the ventricular assist device (vad) exhibited a rise in power. Approximately two days later, the vad exhibited high watt alarms. It was further reported that the vad exhibited a grinding sound upon auscultation, elevated lactate dehydrogenase(ldh) of 2060 and dark urine due to an ascending driveline infection that subsequently caused a vad thrombus. It was noted that the patient was compliant with their anticoagulation therapy. The patient was started on heparin and escalated to bivalirudin the following day. Cultures and a white blood cell count were performed, and the patient was given antibiotics. The patient was escalated to meropenem due to the resistance of several antibiotics. It was further reported the patient¿s vad was decommissioned due to the power being 24w and the outflow graft was surgically closed. The patient was expected to be transplanted and remained stable while on milrinone. 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. If information is provided in the future, a supplemental report will be issued.
 
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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 Key14918057
MDR Text Key295266878
Report Number3007042319-2022-06389
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
Report Date 07/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2018
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/27/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/31/2016
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: 07/05/2022 Patient Sequence Number: 1
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