• 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/DRIVELINE; 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/DRIVELINE; VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 1104
Device Problems Disconnection (1171); Increase in Suction (1604); Pumping Problem (3016)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the ventricular assist device (vad) exhibited a fluctuation in speed, the revolutions per minute (rpm's) were set at 2200 and going down to 2180 and back up to 2280, it was thought to be caused by the lavare cycle being on.It was also noted that a driveline disconnection occurred as well as continuous suction events.The vad remains in use.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Additional products: brand name: heartware ventricular assist system ¿controller 2.0 model #: 1420, catalog #: 1420, expiration date: 30-jun-2021, serial or lot #: (b)(4), udi #: (b)(4).Device available for evaluation: no, device evaluated by mfr: no, device evaluation anticipated, but not yet begun, mfg date: 23-jun-2020, 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.
 
Manufacturer Narrative
A supplemental report is being submitted for device evaluation.Product event summary: the ventricular assist device (vad) and the controller were not returned for evaluation.Log file analysis revealed that the pump's power consumption was within normal operating range between (b)(6) 2021.No alarms or suction events were logged within the analyzed period.As a result, the reported suction and driveline disconnection events were not confirmed.Review of the controller log files also revealed that the lavare cycle was active at the time of the reported event.When active, the lavare cycle decreases the pump speed below the set speed for 2 seconds, then increases the pump speed above the set speed for 1 second before returning to the original set speed for 60 seconds.As a result, the reported speed fluctuation event was confirmed.Review of the data log file revealed that there were no gaps in the data; data points were recorded at an interval of 15 minutes, as expected.However, the reported gap on (b)(6) 2021 and the observed gap on (b)(6) 2021 on the attached log files report correspond with time changes associated with daylight saving time (the clock change occurs on (b)(6) 2021 in great britain and on (b)(6) 2021 in the united states).The gap in the visualization of the data appears due to a difference between the time in the controller and the time the monitor which is compiling the log file data.It is likely that this observed gap was perceived as being due to a driveline disconnection.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.The most likely root cause for the reported speed fluctuations can be attributed to activation of the lavare cycle.Based on the available information, the most likely root cause of the gap in the visualization of the data can be attributed to a difference in time settings due to the clock change associated with daylight saving time.Additional products: d4: con412430 h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
Type of Device
VENTRICULAR (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 Key12820340
MDR Text Key285395509
Report Number3007042319-2021-08051
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUK
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/30/2022
Device Model Number1104
Device Catalogue Number1104
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-