MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-85

Device Problem Microbial Contamination of Device (2303)

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

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in oklahoma city, oklahoma.Through follow-up communication livanova learned that: the device is cleaned regularly per the instruction for use h2o2 is checked daily device is stored full of water when not used and h2o2 is checked daily pall filter is used for tap water and is changed after each use aerosol collection set is replaced after the allowed use period field blue tubing set is replaced each year disposable gloves are used only for hc 3t device during cleaning water circuits and device surfaces are cleaned as per instruction for use and with recommended products the device is used in connection with other devices with clear tubing the sink water was not tested and the source of contamination was not investigated at the customer site the device is used inside the operating theater with the fan directed opposite to the patient at an estimated distance of 15-20 feet if any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report that a heater cooler 3t system tested positive for mycobacterium after disinfection.Reportedly, the customer did not follow instruction for use for a while.There was no patient injury.

Manufacturer Narrative

H10: despite no evident or systematic deviation from device instruction for use could be identified in this specific case, however, the source of contamination is most likely related to location where device is used / stored.

Event Description

See initial report.

• 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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15672376
• MDR Text Key: 302857412
• Report Number: 9611109-2022-00541
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• 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,Followup
• Report Date: 12/22/2022

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: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2012
• 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