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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 Failure to Pump (1502); Pumping Stopped (1503); Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2021
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-dec-2019 / serial #: (b)(4), udi #: (b)(4), no, device evaluation anticipated, but not yet begun, mfg date: 31-dec-2018, patient ime code(s): (b)(4), imf code(s): (b)(4), (b)(4), heartware ventricular assist system ¿ controller 2. 0, model #: 1420 / catalog #: 1420 / expiration date: 30-sep-2018 / serial #: (b)(4), udi #: (b)(4), no, device evaluation anticipated, but not yet begun, mfg date: 30-sep-2017, patient ime code(s): (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the ventricular assist device (vad) would not restart after a controller exchange and exhibited a vad stopped alarm. Multiple controllers were attempted before successfully restarting the vad. The patient was intubated and induced in preparation for a vad exchange, but another attempt was made to restart the vad and was successful. The vad remains in use. No 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 Key11282612
MDR Text Key233329857
Report Number3007042319-2021-00542
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Model Number1104
Device Catalogue Number1104
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 Received06/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/04/2017
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: 02/04/2021 Patient Sequence Number: 1
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