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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 Increase in Suction (1604); Adverse Event Without Identified Device or Use Problem (2993); Pumping Problem (3016)
Patient Problems Dehydration (1807); Hemorrhage/Bleeding (1888)
Event Date 04/08/2021
Event Type  Injury  
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 patient was admitted for a suspected gastrointestinal bleed (gib) due to the fact the patient's hemoglobin (hgb) had dropped. An esophagogastroduodenoscopy (egd) was performed, which showed no findings. The patient received one unit of fresh frozen plasma (ffp) and two units of packed red blood cells (prbc). It was noted that the patient also had some epistaxis during admission, but there was no intervention done and it resolved on it's own. The patient's anticoagulation was seen to be subtherapeutic, and had been on aspirin and coumadin, but was seen to be non compliant with their anticoagulation medications. 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/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 Key11863434
MDR Text Key251944824
Report Number3007042319-2021-03691
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00888707003261
UDI-Public00888707003261
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 04/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2022
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/30/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/24/2020
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: 05/21/2021 Patient Sequence Number: 1
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