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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 Display or Visual Feedback Problem (1184); Failure to Pump (1502); Pumping Stopped (1503); Battery Problem (2885); Power Problem (3010); Pumping Problem (3016)
Patient Problems Chest Pain (1776); Nausea (1970); Anxiety (2328); Heart Failure/Congestive Heart Failure (4446)
Event Date 02/24/2021
Event Type  Death  
Manufacturer Narrative
Concomitant medical products: 5568-53 lead implanted (b)(6)2006; 429688 lead, 6935m62 lead implanted (b)(6) 2013. Additional products: heartware ventricular assist system  controller 2. 0. Model #: 1420 / catalog #: 1420 / expiration date: 30-jun-2021 / serial #: (b)(4). Udi #: (b)(4). Device evaluated: yes, return date: 03-mar-2021. No, device evaluation anticipated, but not yet begun dev rtn to mfr? yes. Mfg date: 17-jun-2020. Labeled for single use: no. (b)(4). (b)(4). Heartware ventricular assist system  controller 2. 0. Model #: 1420 / catalog #: 1420 / expiration date: 30-jun-2021 / serial #: (b)(4). Udi #: (b)(4). Device evaluated: yes, return date: 03-mar-2021. No, device evaluation anticipated, but not yet begun dev rtn to mfr? yes. Mfg date: 17-jun-2020. Labeled for single use: no. (b)(4). (b)(4). Heartware ventricular assist system  controller ac adapter. Model #: 1430 / catalog #: 1430 / expiration date: 27-apr-2019 / serial #: (b)(4). Udi #: (b)(4). Device evaluated: yes, return date: 03-mar-2021. No, device evaluation anticipated, but not yet begun dev rtn to mfr? yes. Mfg date: 27-apr-2018. Labeled for single use: no. Labeled for single use: no. (b)(4). Heartware ventricular assist system  controller ac adapter. Model #: 1430 / catalog #: 1430 / expiration date: 27-apr-2019 / serial #: (b)(4). Udi #: (b)(4). Device evaluated: yes, return date: 03-mar-2021 no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes mfg date: 27-apr-2018. Labeled for single use: no. (b)(4). Heartware ventricular assist system  battery. Model #: 1650 / catalog #: 1650 / expiration date: 31-may-2019 / serial #: (b)(4). Udi #: (b)(4). Device evaluated: yes, return date: 03-mar-2021 no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes. Mfg date: 16-may-2018. (b)(4). (b)(4). Heartware ventricular assist system  battery. Model #: 1650 / catalog #: 1650 / expiration date: 31-may-2019 / serial #: (b)(4). Udi #: (b)(4). Device evaluated: yes, return date: 03-mar-2021 no, device evaluation (b)(4). Heartware ventricular assist system  battery. Model #: 1650 / catalog #: 1650 / expiration date: 30-jun-2019 / serial #: (b)(4). Udi #: (b)(4). Device evaluated: yes, return date: 03-mar-2021 no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes. Mfg date: 02-jun-2018. Labeled for single use: no. (b)(4). Heartware ventricular assist system  battery. Model #: 1650 / catalog #: 1650 / expiration date: 31-may-2019 / serial #: (b)(4). Udi #: (b)(4). Device evaluated: yes, return date: 03-mar-2021 no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes. Mfg date: 16-may-2018. Labeled for single use: no. (b)(4). B)(4). Heartware ventricular assist system  battery. Model #: 1650 / catalog #: 1650 / expiration date: 31-may-2019 / serial #: (b)(4). Udi #: (b)(4). Device evaluated: yes, return date: 03-mar-2021 no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes. Mfg date: 07-may-2018. Labeled for single use: no. (b)(4). (b)(4). Additional information has been requested regarding the vad implant date, 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. Investigation of this event is pending and a supplemental report will be sent upon its completion.
 
Event Description
It was reported that the patient was admitted for a prophylactic controller exchange and they were asymptomatic. The patient did not want a vad exchange if the vad was not able to restart and they requested to be do not resuscitate (dnr)/do not intubate (dni). Following the exchange to a new primary controller, the controller turned on and the ventricular assist device (vad) exhibited greater than 25 watts, flow greater than 10 liters and speed fluctuating between zero and 700 or so rpms with a maximum of 1100 rpm. Multiple attempts were made to cycle power to the controller and the new primary controller was subsequently exchanged with a new backup controller. The new primary controller and new backup controller were exchanged frequently and exhibited unexpected losses of power. The vad exhibited multiple vad stopped alarms, and one of the controllers exhibited a blank screen and loud continuous tone alarm as if there had been a double power source disconnection despite power being connected. Power source exchanges with the five batteries and two controller ac (ac) adapters were attempted and the issue resolved. One of the batteries exhibited a communication error associated with a power disconnect alarm. The ventricular assist device (vad) did not restart and following a consensus that controller exchanges and vad restart attempts had been exhausted, the vad driveline was disconnected. The patient subsequently experienced nausea, chest pain and worsening heart failure. Once the vad was unable to restart, the patient received dobutamine, oxygen via nasal cannula, and intravenous (iv) morphine and a nitroglycerine drip. It was noted that the plan was to continue inotropes and initiatehospice care. The vad remains implanted but out of service. 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 avenue
miami lakes FL 33014
Manufacturer (Section G)
HEARTWARE, INC.
14400 nw 60th avenue
miami lakes FL 33014
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key11425697
MDR Text Key243333728
Report Number3007042319-2021-01841
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,User Facility,Company Representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2021
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? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/11/2018
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: 03/05/2021 Patient Sequence Number: 1
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