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 Bacterial Infection (1735)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

Patient id, age or dob, sex, weight, ethnicity: 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 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 (b)(6).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 male patient underwent cardiac surgery for left ventricular assist device on april 18, 2019 and exploratory surgery of post -op wound on august 24, 2021, september 7, 2021, and december 14, 2021.It was reported that cultures taken from patient on december 14, 2021 grew m.Chimaera.The serial number of device used during surgery is unknown.Reportedly, the patient is living and on oral and intravenous antibiotics.

Manufacturer Narrative

H10: despite attempt to retrieve additional information from the customer, no further detail was provided.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.Through follow-up communication with the chief perfusionist under previous case from the same hospital occurred in the same period (april 2019), livanova 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.A relationship between device and reported event could not be determined.

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
• MDR Report Key: 14307110
• MDR Text Key: 293346490
• Report Number: 1718850-2022-01007
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/06/2022
• Supplement Dates Manufacturer Received: 11/17/2022
• Supplement Dates FDA Received: 11/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other