Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY 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
 

LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16-02-80
Device Problem Failure to Pump (1502)
Patient Problem No Patient Involvement (2645)
Event Date 12/13/2018
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and traced the failure to a defective pump bearing.The technician replaced the pump to resolve the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova (b)(4) received a report that a heater-cooler system 3t patient pump did not work during maintenance.There was no patient involvement.
 
Event Description
See initial.
 
Manufacturer Narrative
The affected pump has been requested back to the manufacturer site for a detailed investigation.Results revealed that the pump motor had a bearing damage, as the bearing was rusted.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEATER-COOLER SYSTEM 3T
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key8260103
MDR Text Key133536313
Report Number9611109-2019-00038
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number16-02-80
Was the Report Sent to FDA? No
Date Manufacturer Received04/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-