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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 Problems Disconnection (1171); Failure to Pump (1502); Pumping Stopped (1503); Power Problem (3010)
Patient Problems Heart Failure/Congestive Heart Failure (4446); Respiratory Insufficiency (4462)
Event Date 02/26/2021
Event Type  Injury  
Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion. Additional products: heartware ventricular assist system controller 2. 0 model #: 1420 / catalog #: 1420, expiration date: 31-jan-2019 / serial #: (b)(4). Udi #: (b)(4). Device evaluated by mfr: no, device evaluation anticipated, but not yet begun. Mfg date: 31-jan-2018. Labeled for single use: no (b)(4). Heartware ventricular assist system controller 2. 0: model #: 1420 / catalog #: 1420. Expiration date: 30-nov-2019 / serial #: (b)(4). Udi #: (b)(4). Device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun. Mfg date: 15-nov-2018. Labeled for single use: no. (b)(4). Additional information has been requested regarding the vad disposition of the event, but it was not available at the time of this report. If additional information is received, the event will be updated and a supplemental report will be sent. 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 accidently double disconnected their power sources on the controller. The patient was able to restore power but shortly after the controller exhibited a vad stop alarm. The patient exchanged their primary controller to the spare controller and the vad would run for a few minutes and the vad stop alarm reoccurred. On their way to the hospital, the patient was swapping between controllers, each time one alarmed, and despite repeated attempts to power cycle the vad between the primary and back up controller, the vad would not come up to speed or remain on. It was seen that the controller also exhibited multiple unexpected power losses. Upon admission to the intensive care unit (icu), the patient started to exhibit worsening heart failure symptoms and was started on inotropes, and the ejection fraction of the heart was noted to be at thirty percent (30%). The patient was transported to another hospital and is currently waiting for a heart transplant. The vad remains in the patient but the driveline was cut, and the controllers were removed from 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 Key11455756
MDR Text Key250906357
Report Number3007042319-2021-01906
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 company representative,health
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/29/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0946-2021

Patient Treatment Data
Date Received: 03/10/2021 Patient Sequence Number: 1
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