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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 Microbial Contamination of Device (2303)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/12/2019
Event Type  malfunction  
Manufacturer Narrative
There was no known 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) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova(b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova (b)(4) initiated an investigation.A review of the dhr did not identify any deviations or non-conformities relevant to 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 device was found to be contaminated with mycobacterium chelonae.There was no known patient involvement.
 
Event Description
See initial report.
 
Manufacturer Narrative
Through follow-up communication livanova deutschland learned that the device was cleaned regularly per the instruction for use and that it was placed inside the operating theatre during using with the fan opposite to the patient at an estimated distance between the surgery field and the device of about 3 meters.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
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Brand Name
HEATER-COOLER SYSTEM 3T
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND GMBH
lindberghstr. 25
munich
MDR Report Key9361047
MDR Text Key196154054
Report Number9611109-2019-00911
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 Notification
Type of Report Initial,Followup
Report Date 12/24/2019
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 10/26/2019
Initial Date FDA Received11/22/2019
Supplement Dates Manufacturer Received11/26/2019
Supplement Dates FDA Received12/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-2076/2081-2015
Patient Sequence Number1
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