BEUDAMED
    FDA Adverse Event Death Summary report: N

    SORIN HEATER-COOLER SYSTEM 3T

    MDR report key: 5179019 · Received October 26, 2015

    Report

    Report Number
    9611109-2015-00503
    Event Type
    Death
    Date Received
    October 26, 2015
    Report Date
    August 14, 2015
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. EVENT DATE. THE FACILITY DID NOT PROVIDE THE EVENT DATE. THIS INFORMATION WILL BE PROVIDED IN A FOLLOW-UP REPORT IF IT BECOMES AVAILABLE. PMA 510(K). 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 (510K#: K052601). SORIN GROUP (B)(4) MANUFACTURES THE SORIN HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT A PATIENT WAS DIAGNOSED WITH MYCOBACTERIAL PROSTHETIC VALVE ENDOCARDITIS AND AORTIC ROOT ABSCESS APPROXIMATELY 10 MONTHS AFTER UNDERGOING AORTIC VALVE REPLACEMENT SURGERY WHICH INVOLVED THE USE OF THE SORIN HEATER-COOLER SYSTEM 3T. IT WAS ALSO REPORTED THAT TESTING PERFORMED BY THE HOSPITAL FOUND ONE OF THE HEATER-COOLER SYSTEMS AT THE FACILITY TO BE CONTAMINATED. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT A PATIENT WAS DIAGNOSED WITH MYCOBACTERIAL PROSTHETIC VALVE ENDOCARDITIS AND AORTIC ROOT ABSCESS APPROXIMATELY 10 MONTHS AFTER UNDERGOING AORTIC VALVE REPLACEMENT SURGERY WHICH INVOLVED THE USE OF THE SORIN HEATER-COOLER SYSTEM 3T. IT WAS ALSO REPORTED THAT TESTING PERFORMED BY THE HOSPITAL FOUND ONE OF THE HEATER-COOLER SYSTEMS AT THE FACILITY TO BE CONTAMINATED. FOLLOW-UP COMMUNICATION WITH THE CUSTOMER REVEALED THAT THE PATIENT DIED FROM THE MYCOBACTERIA INFECTION, BUT IT COULD NOT BE CONFIRMED THAT THE STRAIN FOUND IN THE PATIENT WAS THE SAME AS THE STRAIN FROM THE CONTAMINATED UNIT. A REVIEW OF THE DHR COULD NOT IDENTIFY ANY DEVIATIONS OR NONCONFORMITIES RELEVANT TO THE ISSUE. EVALUATED ON SITE BY SORIN SERVICE REP.

    Additional Manufacturer Narrative · 1

    PT GENDER. MALE. OUTCOME ATTRIBUTED TO: DEATH. EVENT DATE. (B)(6) 2015. SORIN IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF SORIN HEATER COOLER DEVICES. THE Z NUMBER IS Z-2076/2081-2015. SORIN GROUP DEUTSCHLAND (B)(4) RECEIVED A REPORT THAT A PATIENT WAS DIAGNOSED WITH MYCOBACTERIAL PROSTHETIC VALVE ENDOCARDITIS AND AORTIC ROOT ABSCESS APPROXIMATELY 10 MONTHS AFTER UNDERGOING AORTIC VALVE REPLACEMENT SURGERY WHICH INVOLVED THE USE OF THE SORIN HEATER-COOLER SYSTEM 3T. IT WAS ALSO REPORTED THAT TESTING PERFORMED BY THE HOSPITAL FOUND ONE OF THE HEATER-COOLER SYSTEMS AT THE FACILITY TO BE CONTAMINATED. FOLLOW-UP COMMUNICATION WITH THE CUSTOMER REVEALED THAT THE PATIENT DIED FROM THE MYCOBACTERIA INFECTION, BUT IT COULD NOT BE CONFIRMED THAT THE STRAIN FOUND IN THE PATIENT WAS THE SAME AS THE STRAIN FROM THE CONTAMINATED UNIT. A SORIN GROUP SERVICE TECHNICIAN WAS DISPATCHED TO THE FACILITY TO INSPECT CONTAMINATED DEVICE AND A VISUAL INSPECTION OF THE OUTER AND INNER PARTS OF THE HEATER-COOLER UNIT WAS PERFORMED. THE INSPECTION OF THE SORIN HEATER-COOLER SYSTEM 3T REVEALED RESIDUALS AND BIOFILM IN SEVERAL LOCATIONS, MAINLY THE LOWER OVERFLOW TUBING. BASED ON THE OBVIOUS BIOFILM FOUND IN THE WATER CIRCUITS OF THE DEVICES INSPECTED, IT WAS CONCLUDED THAT THIS ISSUE WAS THE RESULT OF THE USER FAILING TO ADHERE TO THE CLEANING AND DISINFECTION INSTRUCTIONS OUTLINED IN THE IFU. AFTER INTENSIVE DISINFECTION CYCLES, WATER SAMPLES TAKEN FROM THE UNIT NO LONGER SHOW CONTAMINATION. AS CORRECTIVE ACTION, FSCA 9611109-06/03/15-002-C WAS RELEASED TO REMIND OUR CUSTOMERS ABOUT THE IMPORTANCE OF ADHERING TO THE WATER MANAGEMENT AND DISINFECTION PROCEDURE. EVALUATED ON SITE BY SORIN SERVICE REP.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT A PATIENT WAS DIAGNOSED WITH MYCOBACTERIAL PROSTHETIC VALVE ENDOCARDITIS AND AORTIC ROOT ABSCESS APPROXIMATELY 10 MONTHS AFTER UNDERGOING AORTIC VALVE REPLACEMENT SURGERY WHICH INVOLVED THE USE OF THE SORIN HEATER-COOLER SYSTEM 3T. IT WAS ALSO REPORTED THAT TESTING PERFORMED BY THE HOSPITAL FOUND ONE OF THE HEATER-COOLER SYSTEMS AT THE FACILITY TO BE CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708519 SORIN HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC SORIN GROUP DEUTSCHLAND 16-02-80 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other