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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 Failure to Pump (1502); Pumping Stopped (1503); Power Problem (3010)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/23/2021
Event Type  Injury  
Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion. Heartware ventricular assist system ¿ controller 2. 0, model #: 1420 / catalog #: 1420 / expiration date: 31-aug-2019 / serial #: (b)(4), udi #: (b)(4). Device available for evaluation: yes. 03-mar-2021. Device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun. Device manufacture date: 28-aug-2018. Labeled for single use: yes, 03-mar-2021. (b)(4). Heartware ventricular assist system ¿ controller 2. 0, model #: 1420 / catalog #: 1420 / expiration date: 31-aug-2019 / serial #: (b)(4), udi #: (b)(4). Device available for evaluation: no. Device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun. Device returned to manufacturer?: yes. Manufacturing date: 28-aug-2018. Labeled for single use: yes, 03-mar-2021. Heartware ventricular assist system ¿ controller 2. 0, model #: 1420 / catalog #: 1420 / expiration date: 30-nov-2021 / serial #: (b)(4), udi #: (b)(4). Device available for evaluation: no. Device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun. Manufacturing date: 17-nov-2020. Labeled for single use: no.
 
Event Description
It was reported that the patient was admitted for an elective controller exchange. The ventricular assist device (vad) failed to restart after the controller exchange, resulting in several vad stopped alarms. The new controller was power cycled and changed to the patient¿s previous backup controller and then switched to another controller in an effort to restart the vad with no success. All three controllers also exhibited unexpected losses of power. The vad was exchanged and two controllers were replaced. One controller 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 Key11414393
MDR Text Key243147170
Report Number3007042319-2021-01809
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
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 05/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2018
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: 03/04/2021 Patient Sequence Number: 1
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