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U.S. Department of Health and Human Services

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

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LIVANOVA DEUTSCHLAND GMBH 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 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). Through follow-up communication it can be highlighted that the device is cleaned regularly according to the instruction for use. The water quality monitoring is not applied and the hydrogen peroxide concentration check is not performed every day as prescribed by ifu. Moreover, the device is placed inside the operation theatre but in the opposite side respect to the patient and the hospital user does not use reusable heating blankets for the patient. The device will be sent to the manufacturer site for deep disinfection in order to solve the reported issue. Based on the above, the root cause of the reported event can be traced back to a user error in following the cleaning procedure as described in the ifu. Livanova has implemented a strategy to progressively decrease the probability of bacteria grow in the hc device by applying multiple measures implemented over the past few years. 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 heater cooler device contaminated with mnt chimaera, the customer required dd procedure. Even if in the microbiological test the number of the device reported is (b)(4) but in reality the correct serial is (b)(4).

 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND GMBH
lindberghstr. 25
munich 80939
GM 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND GMBH
lindberghstr. 25
munich 80939
GM 80939
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key10429847
MDR Text Key204599211
Report Number9611109-2020-00471
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 07/21/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/20/2020
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 Received07/21/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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