BEUDAMED
    FDA Adverse Event Death Summary report: N

    SORIN HEATER-COOLER SYSTEM

    MDR report key: 5448313 · Received February 19, 2016

    Report

    Report Number
    9611109-2016-00047
    Event Type
    Death
    Date Received
    February 19, 2016
    Date of Event
    June 1, 2012
    Report Date
    March 8, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODEL NUMBER WAS NOT PROVIDED, SO IT IS UNCLEAR WHETHER A SORIN HEATER-COOLER SYSTEM 3T (510K#: K052601) OR A SORIN HEATER-COOLER SYSTEM 1T (NOT DISTRIBUTED IN USA) WAS INVOLVED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF AND WHEN MADE AVAILABLE. THE MODEL AND SERIAL NUMBER WERE NOT DISCLOSED BY THE FACILITY. THIS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF AND WHEN MADE AVAILABLE. THE MODEL NUMBER WAS NOT PROVIDED, SO THE 510(K) NUMBER IS UNKNOWN. THIS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF AND WHEN MADE AVAILABLE. THE SERIAL NUMBER WAS NOT PROVIDED, SO THE MANUFACTURE DATE IS UNKNOWN. THIS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF AND WHEN MADE AVAILABLE. 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 A PATIENT EXPERIENCED MYCOBACTERIA CHIMAERA ENDOCARDITIS IN ASSOCIATION WITH A SURGICAL PROCEDURE PERFORMED IN (B)(6) 2012 THAT UTILIZED A SORIN HEATER-COOLER SYSTEM. THE PATIENT (B)(6), WHO HAD AN AORTIC VALVE ENDOPROSTHESIS, WAS HOSPITALIZED ON (B)(6) 2015 FOR ENDOCARDITIS, PARAVALVULAR LEAKAGE AND PARAVALVULAR ABSCESS WITH SEPSIS. THE AORTIC VALVE WAS REPLACED ON THE SAME DAY. THE FOLLOWING DAY, (B)(6) 2015, THE PATIENT EXPIRED DUE TO THE POST-OPERATIVE INFECTION. THE AORTIC VALVE TISSUE UNDERWENT MICROBIOLOGICAL EXAMINATION ON (B)(6) 2015. A HIGH NUMBER OF ACID-FAST RODS WERE IDENTIFIED. MYCOBACTERIA CHIMAERA COULD BE CONFIRMED VIA DNA SEQUENCING. THE RESULT WAS ALSO CONFIRMED BY THE NATIONAL REFERENCE CENTER (NRC) FOR MYCOBACTERIA (BORSTEL). BASED ON THESE RESULTS, THE CUSTOMER CAME TO THE CONCLUSION THAT THE INFECTION WAS CAUSED BY M. CHIMAERA. ATTEMPTS AT CULTURING HAVE FAILED SO FAR. THE MODEL AND SERIAL NUMBER HAVE NOT BEEN PROVIDED BY THE FACILITY. THE FACILITY OWNS BOTH SORIN HEATER-COOLER SYSTEM 3T UNITS AND SORIN HEATER-COOLER SYSTEM 1T UNITS (WHICH ARE NOT DISTRIBUTED IN THE USA), SO IT IS UNKNOWN WHICH SYSTEM WAS INVOLVED IN THE EVENT. 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. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SEVERAL ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER AND RETRIEVE ADDITIONAL INFORMATION REGARDING PATIENT DETAILS AND THE INVOLVED DEVICE. NO FURTHER INFORMATION WAS PROVIDED DURING THESE FOLLOW-UP ATTEMPTS. HOWEVER, DURING FOLLOW-UP COMMUNICATION MADE INDEPENDENTLY FROM THIS EVENT, THE CUSTOMER DISCLOSED THAT THE FACILITY'S HEATER-COOLER DEVICES HAVE BEEN REMOVED FROM SERVICE AND QUARANTINED BY THE MEDICAL ENGINEERING DEPARTMENT UNTIL A "REWORK" CAN BE PERFORMED. ADDITIONAL DETAILS ABOUT THE REWORK AND WHEN IT WILL BE COMPLETED WERE NOT PROVIDED. NO INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT A PATIENT EXPERIENCED MYCOBACTERIA CHIMAERA ENDOCARDITIS IN ASSOCIATION WITH A SURGICAL PROCEDURE PERFORMED IN (B)(6) 2012 THAT UTILIZED A SORIN HEATER-COOLER SYSTEM. THE PATIENT (B)(6), WHO HAD AN AORTIC VALVE ENDOPROSTHESIS, WAS HOSPITALIZED ON (B)(6) 2015 FOR ENDOCARDITIS, PARAVALVULAR LEAKAGE AND PARAVALVULAR ABSCESS WITH SEPSIS. THE AORTIC VALVE WAS REPLACED ON THE SAME DAY. THE FOLLOWING DAY, (B)(6) 2015, THE PATIENT EXPIRED DUE TO THE POST-OPERATIVE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103225 SORIN HEATER-COOLER SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC SORIN GROUP DEUTSCHLAND UNKNOWN N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death