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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 Hemorrhage/Bleeding (1888); Renal Failure (2041); Sepsis (2067); Septic Shock (2068)
Event Date 06/23/2022
Event Type  Death  
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.
 
Event Description
It was reported that the ventricular assist device (vad) patient was admitted from a skilled nursing facility (snf) in acute renal failure with digoxin toxicity, fecal impaction with gastrointestinal bleeding, and shock related to sepsis. Despite appropriate therapeutic measures, including fecal disimpaction, antibiotic therapies, continuous renal replacement therapy (crrt), and pressor support, the patient continued to decline. The patient was transitioned to comfort measures and passed away peacefully.
 
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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 Key15117576
MDR Text Key296747291
Report Number3007042319-2022-06742
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
Type of Report Initial
Report Date 07/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2017
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/30/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 07/27/2022 Patient Sequence Number: 1
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