BEUDAMED
    FDA Adverse Event Summary report: N

    SORIN HEATER-COOLER SYSTEM 3T

    MDR report key: 5982182 · Received September 27, 2016

    Report

    Report Number
    9611109-2016-00677
    Date Received
    September 27, 2016
    Report Date
    March 30, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWC
    PMA / PMN Number
    K052601
    Removal / Correction Number
    Z-2076/2081-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT PROVIDE THE EVENT DATE. THE INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF AND WHEN MADE AVAILABLE. SORIN IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF SORIN HEATER-COOLER DEVICES. THE Z NUMBER IS (B)(4). 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 (B)(4) RECEIVED A REPORT THAT THE SORIN HEATER-COOLER SYSTEM 3T TESTED POSITIVE FOR NONTUBERCULOUS MYCOBACTERIUM (NTM). THERE IS NO KNOWN PATIENT INVOLVEMENT. THE CUSTOMER ALSO STATED IN THE REPORT THAT THREE CONSECUTIVE DISINFECTION CYCLES WERE PERFORMED USING MINNCARE DUE TO THE CONTAMINATION. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). DURING FOLLOW-UP COMMUNICATION, THE CUSTOMER INFORMED LIVANOVA (B)(4) THAT THE HOSPITAL MANAGEMENT WAS CONCERNED WITH SHARING SOME OF THE REQUESTED INFORMATION WITH THE COMPANY. HOWEVER, IT WAS DISCLOSED THAT THE HEATER-COOLER 3T SYSTEMS AT THE FACILITY ARE NOT IN REGULAR USE AND ARE PUT IN A HOLDING PATTERN WHILE THE FACILITY WAITS FOR THE RESULTS TO COME BACK FROM THE LAB. HOWEVER, THE DEVICES MAY STILL BE USED IF IT IS REQUIRED DUE TO A LACK OF EQUIPMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. AS CORRECTIVE ACTION, A FIELD SAFETY NOTICE HAS BEEN RELEASED TO REMIND OUR CUSTOMERS ABOUT THE IMPORTANCE OF ADHERING TO THE WATER MANAGEMENT AND DISINFECTION PROCEDURE OUTLINED IN THE CURRENT INSTRUCTIONS FOR USE (IFU). DEVICES NOT RETURNED.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SORIN HEATER-COOLER SYSTEM 3T TESTED POSITIVE FOR NONTUBERCULOUS MYCOBACTERIUM (NTM). THERE IS NO KNOWN PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631027 SORIN HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC SORIN GROUP DEUTSCHLAND 16-02-82

    Patients

    Seq Age Sex Outcome Treatment
    1