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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)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/21/2022
Event Type  malfunction  
Event Description
It was reported that the ventricular assist device (vad) patient experienced multiple vad stop and vad disconnect alarms. It was also reported that the controllers exhibited multiple power up events indicating loss of power to the controllers. The patient presented to the emergency department with persistent alarms. The patient then proceeded to the hospital where the controller was exchanged to a hospital controller with new power sources. Of note the vad would not restart. Subsequently the vad and both controllers were removed from service. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion. Additional products: brand name: heartware ventricular assist system ¿ controller 2. 0 / model#: 1420 / catalog#: 1420 / expiration date: 31-mar-2021 / serial#:(b)(4) / udi#: (b)(4). / device available for evaluation: no / device evaluated by mfr: no, device evaluation anticipated, but not yet begun / mfg date:13-mar-2020 / labeled for single use: no / (b)(4). Brand name: heartware ventricular assist system ¿ controller 2. 0 / model#: 1420 / catalog#: 1420 / expiration date: 31-nov-2020 / serial#: (b)(4) / udi #: (b)(4) / device available for evaluation: no / device evaluated by mfr: no, device evaluation anticipated, but not yet begun / mfg date: 13-nov-2019 / labeled for single use: no / (b)(4). Additional information has been requested regarding the details 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.
 
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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 Key14982177
MDR Text Key295680343
Report Number3007042319-2022-06460
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 08/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2021
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/28/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/25/2019
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: 07/11/2022 Patient Sequence Number: 1
Treatment
DVFB1D4 ICD, 6935M55 LEAD
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