MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER COOLER 3T (230 VOLT); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-80

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2022

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a heater-coolersystem 3t was contamination by chimaera.There is no patient involvement.The customer has requested deep disinfection.

Manufacturer Narrative

The heater-cooler 16-02-80 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).Correction/removal number: livanova deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in belgium.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 with the customer, livanova was informed that the device is not cleaned regularly according to the instruction for use "aquaconservans" are being used to fill up the device instead of water.Daily h2o2 level check is not performed and h2o2 is not added when the water in the tanks is changed, in disagreement with ifu.Other devices/surfaces in the or/icu were not tested to investigate presence contamination.The sink water has not been tested to investigate presence of mycobacterium contamination the hospital does not use a medical tap filter or any kind of filter.The water circuits are not disinfected prior device storage.The device surfaces are not cleaned prior to use or storage.No information was available regarding the use of blankets, water quality hpc and ntm monitoring and replacement frequency of the aerosol collection.The device is placed outside the operating theater during use and is drained when not in use.Disposable gloves were used only for device cleaning.The heater cooler is not used in connection with other devices.The device operates in connection to a vacuum source during surgery and the vacuum is applied until patient leaves the operating room.The field blue tubing set is replaced every year.The root cause of the contamination could not be determined.It is likely that the deviation from the instruction for use may have led/contributed to the reported contamination.

Event Description

See intial report.

• Brand Name: HEATER COOLER 3T (230 VOLT)
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich CO 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 16049646
• MDR Text Key: 308459120
• Report Number: 9611109-2022-00690
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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: 01/31/2023

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 Number: 16-02-80
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 01/02/2023
• Supplement Dates FDA Received: 01/31/2023
• Date Device Manufactured: 10/02/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1