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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 16-02-85
Device Problem Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Weakness (2145); Weight Changes (2607)
Event Date 07/01/2015
Event Type  Injury  
Manufacturer Narrative

Patient identifier and weight not provided. This information will be provided in a supplemental report if made available. Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices. The z number is (b)(4). Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). Through follow-up communication with the customer livanova learned that the unit was placed inside operation room and were briefly quarantined, but they have started to use them again when they figured out how to place them outside. Further it was reported that the device was cleaned according the instruction for use (ifu). A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. Corrective actions are in progress for the reported issue. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device not returned.

 
Event Description

On (b)(6) 2018, livanova (b)(4) received a user medwatch report ((b)(4)) stating that a patient underwent an aortic aneurysm repair was found to be infected with mycobacterium avium complex. The patient suffered weight loss and weakness due to the infection.

 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key8068144
MDR Text Key127060021
Report Number9611109-2018-01333
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK052601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Remedial Action Notification
Type of Report Initial
Report Date 11/14/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/14/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number16-02-85
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 Received10/16/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/16/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-2076/2081-2015

Patient TREATMENT DATA
Date Received: 11/14/2018 Patient Sequence Number: 1
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