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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 Problem Heart Failure/Congestive Heart Failure (4446)
Event Date 02/22/2021
Event Type  Injury  
Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion. Continuation of device available for evaluation: 1458q lead, implanted: (b)(6) 2014, cd3365-40q, icd, implanted: (b)(6) 2015, 7120q, lead implanted: (b)(6) 2015. 5019, adaptor, implanted: (b)(6) 2016. 6721m-50, lead implanted: (b)(6) 206. Additional products: 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. Device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun. Manufacturing date: 27-aug-2018. Labeled for single use: no. (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. Device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun. Manufacturing date: 29-aug-2018. Labeled for single use: no. (b)(4). Brand name: heartware ventricular assist system ¿ controller 2. 0 model #: 1420 / catalog #: 1420 / expiration date: 28-feb-2021 / serial#: (b)(4), udi #: (b)(4). Device available for evaluation: no. Device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun. Manufacturing date: 19-feb-2020. Labeled for single use: no. (b)(4).
 
Event Description
It was reported that the patient was scheduled for a prophylactic controller exchange, however, once the primary controller was exchanged to the back up controller, the ventricular assist device (vad) failed to restart. The back up controller was then switched to another back up controller, and this controller was seen to have several vad stop alarms and an unexpected power loss with a no power alarm and vad disconnect alarm. The physician then tried to switch back to the primary controller, which also did not restart the vad and also exhibited multiple vad stop alarms and an unexpected power loss with a no power alarm and vad disconnect alarm. The controller exchange was attempted several times between the primary and back up controllers, but the vad was unable to reach the targeted speed goal, and after about 10 minutes the patient became symptomatic with low cardiac output and worsening right heart failure. Intravenous (iv) epinephrine was initiated and then the patient was sent to the operating room (or) for an urgent vad exchange via thoracotomy incision. The original vad sewing ring, outflow graft (ofg), and strain relief were used with the new vad implant. The original vad, primary controller, and first back up controller were exchanged, and the second back up controller remains in use. 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 Key11435528
MDR Text Key249524613
Report Number3007042319-2021-01851
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 company representative,health
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 08/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2021
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
Date Returned to Manufacturer03/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2021
Was Device Evaluated by Manufacturer? Yes
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
Removal/Correction NumberZ-0946-2021

Patient Treatment Data
Date Received: 03/08/2021 Patient Sequence Number: 1
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