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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 Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/08/2020
Event Type  Malfunction  
Manufacturer Narrative

There was no known 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 deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices. The z number is z-2076/2081-2015. Livanova deutschland manufactures the heater-cooler system 3t. The incident occurred in (b)(6). Dhr review did not revealed any non conformities related to this device. Lab test report has been provided to livanova. The unit was not used from the customer after the first positive results and it was put aside and continue weekly cleaning and disinfection while they wait for deep disinfection. The hospital follows the ifu for the water quality monitoring applied and the h2o2 checked. The device was put inside the theatre during use with the fan away about 2-5m to 3 mt to the patient. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

 
Event Description

Livanova received a report about a 3t heater cooler contaminated with "mold". The hospital decided to sent this unit for deep disinfection.

 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key10400451
MDR Text Key204016537
Report Number9611109-2020-00459
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeSN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 07/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/13/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number16-02-80
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/14/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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