• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 1103
Device Problems Increase in Suction (1604); Pumping Problem (3016); Insufficient Information (3190)
Patient Problems Dehydration (1807); Fatigue (1849); Tachycardia (2095)
Event Date 05/20/2022
Event Type  Injury  
Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion. Additional products: brand name: heartware ventricular assist system: battery, model #: 1650 / catalog #: 1650/ expiration date: 31-jul-2021 / serial #: (b)(4), udi #: (b)(4), device available for evaluation: no, device evaluated by mfr: no, device evaluation anticipated, but not yet begun, mfg date: 06-jul-2020, labeled for single use: no, patient ime code(s): (b)(4), imf code(s): (b)(4), img code(s): (b)(4), fda device code(s): (b)(4), fda method code(s): (b)(4), fda results code(s): (b)(4), fda conclusion code(s): (b)(4), brand name: heartware ventricular assist system: battery, model #: 1650 / catalog #: 1650/ expiration date: 31-jul-2021 / serial #: (b)(4), udi #: (b)(4), device available for evaluation: no, device evaluated by mfr: no, device evaluation anticipated, but not yet begun, mfg date: 06-jul-2020, labeled for single use: no, patient ime code(s): (b)(4), imf code(s): (b)(4), img code(s): (b)(4), fda device code(s): (b)(4), fda method code(s): (b)(4), fda results code(s): (b)(4), fda conclusion code(s): (b)(4), brand name: heartware ventricular assist system: controller, 2. 0, model #: 1420 / catalog #: 1420 / expiration date: 28-feb-2022 / serial #: (b)(4), udi #: (b)(4), device available for evaluation: no, device evaluated by mfr: no, device evaluation anticipated, but not yet begun, mfg date: 18-feb-2021, labeled for single use: no, patient ime code(s): (b)(4), imf code(s): (b)(4), img code(s): (b)(4), fda device code(s): (b)(4), fda method code(s): (b)(4), fda results code(s): (b)(4), fda conclusion code(s): (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the ventricular assist device (vad) exhibited several low flow alarms and suction, but the patient felt fine. The low flows were noted to be due to ventricular tachycardia (vt) and dehydration. An echocardiogram and electrocardiogram were performed and the vad speed was lowered. It was noted that the patient always had low flows related to vt which they had history prior to vad implant. Of note, this becomes worse when the patient is on their left side lying down. The patient was treated with medications, fluids, and cardioversion. Of note, the patient had fatigue from always having low flow alarms and it is unknown if the issues they are having are with the batteries. It was further reported that there were five power disconnect alarms on two batteries approximately four days later. Of note, the controller¿s port one was the connection site for the no power connected alarm during the time of the replacement of two batteries. The vad and controller remain in use. The two batteries were replaced. No further patient complications have been reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key14744060
MDR Text Key294942033
Report Number3007042319-2022-05453
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
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 Manufactured10/31/2017
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: 06/20/2022 Patient Sequence Number: 1
-
-