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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); Difficult to Remove (1528)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/08/2022
Event Type  Death  
Event Description
It was reported that the controller was four years old and the site wanted to perform an elective controller exchange to prevent a controller fault alarm triggering. An elective controller exchange was performed, and the pump did not restart when connected to the new controller. The connections were checked to verify that they were secure. The ventricular assist device (vad) speed went up to about 600 revolutions per minute (rpm) then went back down to zero rpm, and it was still alarming ¿vad stopped¿. Two minutes passed but the vad still wasn¿t starting. An attempt was made to connect the old controller, but that would not start the vad either. The new controller was attached again, and it was still alarming ¿vad stopped¿ so the patient was placed on extracorporeal membrane oxygenation (ecmo). It was stated that the controller stayed connected for about 20 minutes while the patient was placed on ecmo, but the vad did not restart. The patient was initially stable on ecmo but decompensated overnight, and an emergent vad exchange was performed. The dissection was difficult which made surgery more complicated. The patient was struggling and not doing well. Care was withdrawn and the patient subsequently died.
 
Manufacturer Narrative
Additional products: brand name: heartware ventricular assist system ¿ controller 2. 0, model #: 1420 / catalog #: 1420 / expiration date: 30-apr-2020 / serial #: (b)(4)/ udi #: (b)(4). Device available for evaluation: yes, return date: 22-apr-2022. Mfg. Date: 10-apr-2019 labeled for single use: yes (b)(4). Additional products: brand name: heartware ventricular assist system ¿controller 2. 0, model #: 1420 / catalog #: 1420 / expiration date: 31-may-2022 / serial #:(b)(4) / udi #: (b)(4). Device available for evaluation: yes, return date: 22-apr-2022, mfg. Date: 27-may-2021. Labeled for single use: yes (b)(4). Investigation of this event is pending and a supplemental report will be sent upon its completion. Additional information has been requested regarding the patient's weight and medical history, 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.
 
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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 Key14220149
MDR Text Key290171454
Report Number3007042319-2022-04863
Device Sequence Number1
Product Code DSQ
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
Report Date 05/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/28/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/04/2018
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: 04/27/2022 Patient Sequence Number: 1
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