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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 1104
Device Problems Increase in Suction (1604); Pumping Problem (3016)
Patient Problems Tachycardia (2095); Respiratory Insufficiency (4462)
Event Date 11/09/2021
Event Type  Injury  
Manufacturer Narrative
This information was received from the (b)(6) destination therapy study. 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 nine suction alarms and one low flow alarm occurred, and approximately five hours later the patient was hospitalized due to respiratory distress. Ventricular tachycardia was observed, and the patient was restored to sinus rhythm using an implantable cardioverter defibrillator (icd). The patient's diuretic and antiarrhythmic medications were adjusted. No recurrence of arrhythmia was observed. The ventricular assist device (vad) remains in use. No further patient complications have been reported as a result of this event.
 
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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 Key12820572
MDR Text Key280823251
Report Number3007042319-2021-08056
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2022
Device Model Number1104
Device Catalogue Number1104
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/30/2020
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: 11/16/2021 Patient Sequence Number: 1
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