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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSIST) BYPASS

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSIST) BYPASS Back to Search Results
Device Problems Failure to Pump (1502); Vibration (1674); Pumping Problem (3016); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/31/2020
Event Type  Injury  
Manufacturer Narrative
This device is used for treatment not diagnosis. The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure. The system is designed for in-hospital and out-of-hospital settings. Additional products: brand name: heartware ventricular assist system ¿ controller, model #: unk/ catalog #: unk / expiration date: unk / serial or lot#: unk, udi #:asku, device available for evaluation: no, device mfg date: unk, labeled for single use: no, (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the controller driveline port was loose and lost it's seal. The controller was exchanged and the ventricular assist device (vad) would not restart, and cycled through 800 revolutions per minute and a high power of 28 watts. The vad was heard to be chugging while attempting to restart and the patient could feel vibrations. The patient was exchanged back to the original controller, the vad did not restart, and a controller fault alarm occurred. The controller was exchanged again and continued to cycle inappropriately. Health care professionals discontinued vad support and the patient was transferred to the catheter lab and reactivated on the transplant list. The patient was transplanted the next day. 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 (ASSIST) 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 Key9818018
MDR Text Key196418895
Report Number3007042319-2020-01702
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 company representative,user f
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 03/11/2020 Patient Sequence Number: 1
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