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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
Catalog Number 16-02-1985
Device Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Date 04/05/2019
Event Type  Injury  
Manufacturer Narrative
Patient information was not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.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 z-2076/2081-2015.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation.A complaints database review revealed other similar events submitted by the same hospital.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova received report of an alleged m.Chimaera infection, no information about date or fact of diagnosis a male patient on (b)(6) 2019 underwent an open-chest cardiac surgical procedure (replacement of aortic root and valve) with cardiopulmonary bypass using a livanova heater/cooler 3t device at university of kansas hospital.At that time the hospital did not follow the specific recommendations by the fda to minimize or eliminate the unreasonable risk of airbone transmission of ntm / m.Chimaera to patients undergoing open-chest cardiac surgical procedures.In (b)(6) 2020, the hc 3t devices used in this hospital were replaced with new version of 3t (vacuum and sealing upgrade).From 19 february 2021 to 16 september 2021 the patient has had clinical worsening due to the recurrence of certain symptoms (e.G.Weight loss, weakness, fatigue, cough, abdominal pain, granulomatous hepatitis, brain fogginess).On (b)(6) 2021 he was diagnosed with chorioretinitis resulting from disseminated m.Chimaera infection; aortic valve was removed and positive culture for m.Chimaera was found in aortic tissue and valve itself.Patient is living.
 
Manufacturer Narrative
Patient information was not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.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 z-2076/2081-2015.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation.A complaints database review revealed other similar events submitted by the same hospital.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova received report of an alleged m.Chimaera infection, no information about date or fact of diagnosis a male patient on (b)(6) 2019 underwent an open-chest cardiac surgical procedure (replacement of aortic root and valve) with cardiopulmonary bypass using a livanova heater/cooler 3t device at (b)(6) hospital.At that time the hospital did not follow the specific recommendations by the fda to minimize or eliminate the unreasonable risk of airbone transmission of ntm / m.Chimaera to patients undergoing open-chest cardiac surgical procedures.In (b)(6) 2020, the hc 3t devices used in this hospital were replaced with new version of 3t (vacuum and sealing upgrade).From (b)(6) 2021 to (b)(6) 2021 the patient has had clinical worsening due to the recurrence of certain symptoms (e.G.Weight loss, weakness, fatigue, cough, abdominal pain, granulomatous (b)(6), brain fogginess).On (b)(6) 2021 he was diagnosed with chorioretinitis resulting from disseminated m.Chimaera infection; aortic valve was removed and positive culture for m.Chimaera was found in aortic tissue and valve itself.Patient is living.
 
Manufacturer Narrative
Through follow-up communication with the chief perfusionist under previous cases from the same hospital, livanova deutschland learned that the water in the heater-cooler systems 3t in use is changed every day and they are stored dry.This is not in alignment with current instruction for use however reportedly the devices in use at the hospital are very clean and there is no sign of biofilm.The devices are located inside the operating theater during use.The result of microbial sampling performed at customer site revealed that two devices in use at the hospital were found to be contaminated.It is not possible to determine if the device used for this specific surgery was one of the two devices confirmed to be contaminated and if the device used was actually contaminated at the time of surgery.No dhr and shr could be performed since no serial number was provided.No device, between the ones in use at the hospital, was upgraded with vacuum and sealing kit at the time of the surgery on (b)(6), 2019.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
See initial report.
 
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Brand Name
HEATER-COOLER SYSTEM 3T
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich 80309
GM   80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key13116604
MDR Text Key285735872
Report Number9611109-2021-00746
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial,Followup
Report Date 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number16-02-1985
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
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