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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Renal Failure (2041); Septic Shock (2068); Cardiogenic Shock (2262); Hypervolemia (2664); Heart Failure/Congestive Heart Failure (4446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/22/2022
Event Type  Death  
Event Description
It was reported that the patient was admitted for cardiogenic shock, septic shock, hypervolemia, worsening right heart failure, and acute kidney injury. It was noted that the patient did not respond to aggressive diuretic therapy and was placed on continuous renal replacement therapy (crrt) along with subsequent intubation, increasing inotrope and vasopressor requirements due to further cardiogenic and septic shock. The patient began to have multisystem organ failure (msof) despite therapies by the cardiovascular (cv) surgery team. The patient condition worsened, and the organ system failure progressed to the point where family discussions began towards comfort measures. The patient was not a candidate for heart transplantation or other supportive interventions. A decision was made by the family to do not resuscitate (dnr) and began the process of withdrawal of vasopressor and inotropic support while providing maximum comfort measures. The patient subsequently expired from right ventricular failure and msof.
 
Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion.
 
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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 Key14171403
MDR Text Key289778627
Report Number3007042319-2022-04775
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00888707002639
UDI-Public00888707002639
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,Followup
Report Date 06/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2020
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/15/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/15/2018
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: 04/21/2022 Patient Sequence Number: 1
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