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U.S. Department of Health and Human Services

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

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LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16-02-80
Device Problem Insufficient Heating (1287)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/30/2021
Event Type  Malfunction  
Manufacturer Narrative

Patient information: 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). Through follow-up communication livanova learned that the device was cleaned as per the instruction for use. In addition livanova learned that in one occasion the disinfectants were circulated in the water tank exceeding the time prescribed by the instruction for use. A livanova field service representative was dispatched to the facility to investigate the device and could confirm particles coming from the nickel layer of the cooling coil. However, the device was found to be properly functioning. Subsequent functional verification testing was completed without further issues and the unit was returned to service. Investigation is still ongoing. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

 
Event Description

Livanova received report that during a procedure while re-warming the patient, 38¿c temperature set on the heater-cooler system could not be reached. The temperature at the level of the inspire 8 oxygenator was 34¿c and the oxygenation performance was within specifications. The oxygenator was changed out within three (3) minutes and the procedure could be completed with no further issues. At the first inspection after device replacement, small black particles were noticed inside the oxygenator. There was no report of patient injury.

 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key11892719
MDR Text Key252894985
Report Number9611109-2021-00292
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/27/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/27/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number16-02-80
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/01/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/11/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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