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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 1104
Device Problem Failure to Pump (1502)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2021
Event Type  Injury  
Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion. Additional products: heartware ventricular assist system ¿ controller 2. 0. Model #: 1420 / catalog #: 1420 / expiration date: 30-nov-2018 / serial or lot#: con316225. Udi #: (b)(4). Device evaluated: no. No, device evaluation anticipated, but not yet begun. Mfg date: 30-nov-2017 h5: no (b)(4). Heartware ventricular assist system ¿ controller 2. 0. Model #: 1420 / catalog #: 1420 / expiration date: 30-nov-2018 / serial or lot#: con316337 udi #: (b)(4). Device evaluated: no. No, device evaluation anticipated, but not yet begun. Mfg date: 30-nov-2017 h5: no (b)(4). Heartware ventricular assist system ¿ controller 2. 0. Model #: 1420 / catalog #: 1420 / expiration date: 31-aug-2021 / serial or lot#: con413180 udi #: (b)(4). Device evaluated: no. No, device evaluation anticipated, but not yet begun. Mfg date: 30-nov-2017 h5: no (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that, after a prophylactic controller exchange, the ventricular assist device (vad) would not restart. After forty five minutes of attempts with different controllers, the vad did not restart. The vad is off and remains in the patient. The original controller was exchanged and the other controllers remain with the patient. No 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 Key11453428
MDR Text Key247503628
Report Number3007042319-2021-01894
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 10/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Model Number1104
Device Catalogue Number1104
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2018
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: 03/10/2021 Patient Sequence Number: 1
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