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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 No Audible Alarm (1019); Electrical /Electronic Property Problem (1198); Failure to Pump (1502); Pumping Stopped (1503); Pumping Problem (3016)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/03/2022
Event Type  Injury  
Manufacturer Narrative
Brand name: heartware ventricular assist system ¿ controller 2. 0, model#: 1420, catalog#: 1420, expiration date: 30-sep-2019 / serial#: (b)(4), udi#: (b)(4). Labeled for single use: no, mfg date: 05 sep-2018. (b)(4). Brand name: heartware ventricular assist system ¿ controller 2. 0. Model#: 1420, catalog#: 1420, expiration date: 31-aug-2019, serial#: (b)(4), udi#: (b)(4). Labeled for single use: no, mfg date: 27 aug-2018. (b)(4). Investigation of this event is pending and a supplemental report will be sent upon its completion. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the ventricular assist device (vad) patient was admitted due to a controller fault and was doing well up until approximately a week prior to the exchange. The patient reported dropping the controller. It was noted that there were no more sounds coming from the controller when performing power source changes and there were no alarms sounded. Fifteen days later while sitting in bed the patient reported the alarm started blaring and notice that the screen read ¿vad stopped¿. The patient was moved to intensive care unit (icu), dobutamine was started, and an attempt was made to restart the vad using the backup controller. The vad ramped up to 480rpm and then stopped and ramped up to 500rpm, then stopped. The exchange was attempted one more time with no success in restarting the vad. A decision was made to abandon attempts at restarting the vad and to perform a vad exchange the following morning. The patient remained stable throughout the night and was taken to the operating room and the vad was exchanged to a competitor device. 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 (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 Key14676708
MDR Text Key293936676
Report Number3007042319-2022-05399
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
Type of Report Initial,Followup
Report Date 06/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2022
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/06/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/24/2018
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: 06/13/2022 Patient Sequence Number: 1
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