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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 16-02-80
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2018
Event Type  malfunction  
Manufacturer Narrative
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).A review of the dhr could not identify any deviations or nonconformities relevant to the issue.Corrective actions are in progress for this 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
Livanova (b)(4) received a report that a heater-cooler system 3t was found to be contaminated with mycobacterium chimaera.There was no known patient involvement.
 
Event Description
See initial.
 
Manufacturer Narrative
Through follow-up communication with the customer, livanova deutschland learned that the device was cleaned according to the instruction for use and placed inside the operation theatre.The device was positioned two meters away from the patient table with the fan directed in the opposite direction of the patient.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Manufacturer Narrative
Through follow up communication, livanova deutschland learned that the hospital used multiple-use heating blankets until march 2019.Those blankets are not included in the heater-cooler system 3t water circuit disinfection, thus are potential source for external contamination.The hospital agreed on changing the approach and use the single use heating blankets.
 
Event Description
See initial.
 
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Brand Name
HEATER-COOLER SYSTEM 3T
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key8205888
MDR Text Key131776188
Report Number9611109-2018-01449
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,Followup
Report Date 06/21/2019
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 Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/04/2018
Initial Date FDA Received12/31/2018
Supplement Dates Manufacturer Received01/14/2019
05/24/2019
Supplement Dates FDA Received02/12/2019
06/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-2076/2081-2015
Patient Sequence Number1
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