BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 6881823 · Received September 21, 2017

    Report

    Report Number
    9611109-2017-00739
    Event Type
    Injury
    Date Received
    September 21, 2017
    Date of Event
    November 7, 2016
    Report Date
    September 21, 2017
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    PMA / PMN Number
    K052601
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE INITIAL REPORT, SUBMITTED SEPTEMBER 21, 2107, THE CONCLUSION CODE WAS SELECTED AS "- INCONCLUSIVE-INVESTIGATION IN PROGRESS." THIS SELECTION WAS ERRONEOUS. THE CONCLUSION CODE SHOULD HAVE BEEN SELECTED AS "- EVALUATION CONCLUSION."

    Additional Manufacturer Narrative · 1

    LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). (B)(4). THROUGH FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, LIVANOVA (B)(4) LEARNED THAT THE DEVICE HAS NOT BEEN TESTED AND WAS PLACED INSIDE THE OPERATION ROOM DURING USE. THE CUSTOMER REPORTED THAT THE DEVICE WAS CLEANED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). IT WAS ALSO REPORTED THAT THE DEVICE WAS REPLACED ON APRIL 8, 2017 AND IS NO LONGER IN USE AT THE FACILITY. IT IS UNKNOWN AT THIS TIME IF THE PATIENT INFECTION IS RELATED TO THE USE OF THE HEATER-COOLER DEVICE. THE CUSTOMER ALSO PROVIDED A USER MEDWATCH REPORT, WHICH STATED THAT THE PROCEDURE AND POST-OP WERE UNEVENTFUL AND THE PATIENT WAS DISCHARGED IN (B)(6) 2016. DURING A WOUND CHECK ON (B)(6) 2017, IT WAS NOTICED THAT THE WOUND WAS NOT HEALING WELL AND THE STERNAL WOUND CULTURES WERE TAKEN A COUPLE DAYS LATER. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. CORRECTIVE ACTIONS ARE IN PROGRESS FOR THIS ISSUE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A MALE PATIENT WHO HAD OPEN HEART SURGERY IN (B)(6) 2016 WAS HOSPITALIZED FOR A STERNAL WOUND INFECTION ON (B)(6) 2017. A HEATER-COOLER SYSTEM 3T WAS REPORTEDLY USED DURING THE PROCEDURE. A SAMPLE TAKEN FROM THE WOUND WAS CULTURED AND CAME BACK POSITIVE FOR MYCOBACTERIUM CHIMAERA. THE PATIENT IS BEING TREATED WITH ANTIBIOTICS AND WILL CONTINUE TO BE EVALUATED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662577 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| O| R