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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); Death (1802)
Event Type  Death  
Manufacturer Narrative

Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

 
Event Description

Through literature review livanova became aware of 9 patients deaths. These patients were found positive to mycobacterium abscessus at (b)(6) hospital. Within the article it is stated that the hospital used heater-cooler 3t systems. Reportedly. All patient had extensive preoperative comorbidities and complicated postoperative courses in addition to mycobacterium abscessus infection. For this reason, it is reportedly uncertain if patient deaths were attributable to mycobacterium abscessus data presented in the article were collected between august 2013 and may 2014 and between december 2014 and june 2015. Moreover, within the article it is stated that despite changes of the instruction for use in 2010 recommending filtered tap water, it was found that water changes were performed with unfiltered tap water for the devices in use at the hospital and that the disinfection procedure was not applied according to the ifu. Cultures from biofilms of heater-cooler devices were negative fro m. Abscessus while the culture from biofilm of the faucet used to fill the units was positive to m. Abscessus. Reportedly, on early may 2015, the hospital changed the approach and followed the ifu.

 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80309
GM 80309
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key10200063
MDR Text Key196569409
Report Number9611109-2020-00382
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK191402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Remedial Action Recall
Type of Report Initial
Report Date 06/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2020
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 Received05/29/2020
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
Removal/Correction NumberZ-2076/2081-2015

Patient TREATMENT DATA
Date Received: 06/26/2020 Patient Sequence Number: 1
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