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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); Power Problem (3010)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/31/2021
Event Type  Death  
Manufacturer Narrative
Additional information has been requested regarding the interventions 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. Additional products: heartware ventricular assist system ¿controller 2. 0, model #: 1420/ catalog #: 1420/ expiration date: 31-dec-2018 / serial#: (b)(4), udi #: (b)(4). Device available for evaluation: no. Mfg date: 31- dec-2017. Labeled for single use: no. (b)(4). Heartware ventricular assist system ¿controller 2. 0, model #: 1420/ catalog #: 1420/ expiration date: 31-aug-2020 / serial#: (b)(4), udi #: (b)(4). Device available for evaluation: no. Mfg date: 20-aug-2019. Labeled for single use: no. (b)(4). Investigation of this event is pending and a supplemental report will be sent upon its completion. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the controller exhibited an unexpected loss of power associated with a ventricular assist device (vad) stop. When power was reapplied the vad did not restart. Then, the controller was exchanged to a back-up controller but the vad still did not restart. The patient called emergency medical services (ems) and was brought to the emergency room (er) with the vad still off. It was decided to not attempt to restart the vad again since the vad had been off for some time. The patient was placed on inotropes and the vad remains implanted but was decommissioned. The patient remains admitted for evaluation of further intervention. 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 Key11292899
MDR Text Key239762661
Report Number3007042319-2021-00576
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00888707002639
UDI-Public00888707002639
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
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2018
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: 02/08/2021 Patient Sequence Number: 1
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