BEUDAMED
    FDA Adverse Event Death Summary report: N

    SORIN HEATER-COOLER SYSTEM 3T

    MDR report key: 6119352 · Received November 21, 2016

    Report

    Report Number
    9611109-2016-00770
    Event Type
    Death
    Date Received
    November 21, 2016
    Date of Event
    July 3, 2015
    Report Date
    February 24, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODEL NUMBER AND THE SERIAL NUMBER OF THE UNIT WERE NOT PROVIDED. AT THE TIME OF THE CARDIAC SURGERY, THE FACILITY ((B)(6)) HAD THREE HEATER-COOLER SYSTEMS. ALL WERE MODEL NUMBER 16-02-80. THE SERIAL NUMBERS FOR THE THREE UNITS ARE: (B)(4). (B)(6). 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 (510(K) NUMBER: K052601). DEVICE MANUFACTURE DATES FOR THE THREE UNITS IN USE AT THE TIME OF THE INITIAL SURGERY: (B)(4)- MAY 2003; (B)(4)- DECEMBER 2005; (B)(4)- DECEMBER 2005. 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 THROUGH FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, SORIN GROUP (B)(4) LEARNED THAT THE FACILITY ((B)(6)) HAS NO RECORDS OF WHICH DEVICE WAS USED ON THE PATIENT. THE CUSTOMER STATED THAT ALL THREE UNITS IN USE BY THE HOSPITAL AT THE TIME OF THE SURGERY IN (B)(6) 2014 ((B)(4)) WERE SCRAPPED AND REPLACED IN 2015. 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 (B)(4). (B)(4) HAS NOT RECEIVED ANY ADDITIONAL INFORMATION REGARDING TEST RESULTS OR THE CLEANING PROCEDURES FOR ANY OF THE HEATER-COOLER DEVICES IN USE AT THE TIME OF THE PATIENT SURGERY. ALL THREE UNITS IN USE AT THE TIME OF SURGERY HAVE BEEN SCRAPPED BY THE FACILITY. THE DHR AND SERVICE HISTORY REVIEWS FOR EACH DEVICE DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. AN EXACT ROOT CAUSE FOR THE CONTAMINATION WAS NOT IDENTIFIED. HOWEVER, AS CORRECTIVE ACTION FOR THIS TYPE OF ISSUE, 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 DISCARDED.

    Description of Event or Problem · 1

    ON OCTOBER 25, 2016, SORIN GROUP (B)(4) RECEIVED A MEDSUN REPORT (MW5065481) STATING THAT A PATIENT DIED FROM A NONTUBERCULOUS BACTERIA INFECTION AFTER UNDERGOING AN AORTIC HEART VALVE REPLACEMENT IN (B)(6) 2014. THE PATIENT WAS INCORRECTLY DIAGNOSED WITH SARCOIDOSIS AND WAS PRESCRIBED STEROIDS AND METHOTREXATE, WHICH LEAD TO A RAPID DECLINE. ON (B)(6) 2016, SORIN GROUP RECEIVED A USER REPORT FROM THE (B)(6) RELATED TO THE SAME CASE, WHICH CONTAINED ADDITIONAL INFORMATION. THE REPORT STATED THAT THE PATIENT EXPIRED ON (B)(6) 2016 FROM ENDOCARDITIS CAUSED BY MYCOBACTERIUM CHIMAERA AT (B)(6) HOSPITAL IN (B)(6). THE REPORT STATED THAT THE ORIGINAL SURGERY TOOK PLACE AT (B)(6). BOTH REPORTS WERE ISSUED BY A FAMILY MEMBER OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767523 SORIN HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC SORIN GROUP DEUTSCHLAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Death