• 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 Electrical Shorting (2926)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2021
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).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 device and could confirm the reported issue.The failure was traced back to a defective compressor.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 tripped the mains power fuse.There was no report of patient injury.
 
Manufacturer Narrative
H.10: the root cause is hole in the evaporator due to the stirring flow in the tanks causing water entering the cooling circuit and damaging the compressor.Corrective action is already in place for this issue.The erosion kit that includes the new design of the pump head of the stirrer motor to prevent a water flow directed to a narrow area of the evaporator coil.The issue occurred almost two years after device upgrade.However, most probably the condition of the evaporator was already compromised before the upgrade to such an extent that the copper was rather degraded.
 
Event Description
See initial report.
 
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
lindberghstrasse 25
munich
MDR Report Key12059408
MDR Text Key266387076
Report Number9611109-2021-00333
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 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 05/25/2021
Initial Date FDA Received06/24/2021
Supplement Dates Manufacturer Received09/24/2021
Supplement Dates FDA Received10/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-