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U.S. Department of Health and Human Services

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

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 1103
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Sepsis (2067); Septic Shock (2068); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/13/2021
Event Type  Death  
Manufacturer Narrative
Concomitant medical products: ddbc3d4, icd - implanted: (b)(6) 2016; 6935m55. Lead, implanted date: (b)(6) 2016. 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.
 
Event Description
It was reported that the patient was admitted for unknown cause of sepsis and went into shock. The patient¿s status declined quickly, and the patient¿s family decided to withdraw care. It was further reported that the patient subsequently expired thereafter. No autopsy was performed, and the cause of death was deemed to be multi-system organ failure (msof).
 
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
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 Key12674098
MDR Text Key277690926
Report Number3007042319-2021-07746
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00888707000017
UDI-Public00888707000017
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,Followup
Report Date 02/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2018
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/14/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/30/2016
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: 10/21/2021 Patient Sequence Number: 1
Treatment
407645 LEAD
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