BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCH-1000

    MDR report key: 11452852 · Received March 10, 2021

    Report

    Report Number
    11452852
    Event Type
    Injury
    Date Received
    March 10, 2021
    Date of Event
    February 10, 2021
    Report Date
    March 9, 2021
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 0

    THE INFECTION CONTROL SERVICE NOTED AN INCREASE IN BURKHOLDERIA INFECTIONS AMONGST PATIENTS ON THE CARDIOTHORACIC ICU. ISOLATES WERE SENT FOR GENOME SEQUENCE TESTING. SIX OF THE PATIENTS HAD CLOSELY RELATED SEQUENCES AND A SEVENTH HAD A POTENTIALLY RELATED SEQUENCE. ALL THE PATIENTS WERE REVIEWED. A COMMON TRAIT AMONGST ALL WAS THE USE OF ECMO FOR CARDIOPULMONARY SUPPORT. THE ECMO DEVICES WERE INVESTIGATED. ECMO DEVICES HAVE A PUMP COMPONENT AND A HEATER COMPONENT. THE HEATER IS NEEDED TO MAINTAIN BODY TEMPERATURE WHILE THE BLOOD IS OUTSIDE THE BODY. THE HEATER HAS A WATER BATH. THE WATER IN THE BATH IS NOT IN CONTACT WITH BLOOD FROM THE PATIENTS BUT IS PRESENT INSIDE THE PATIENT'S ROOM. WATER BATHS WERE CULTURED AND FOUND TO HAVE BURKHOLDERIA. SOME WATER BATHS ALSO HAD A SECOND ORGANISM CALLED CUPRIAVIDUS PAUCULUS. ALL ECMO HEATER DEVICES WERE TAKEN OUT OF SERVICE. THE CULTURE RESULTS SUGGEST THE SOURCE OF THE PATIENTS' INFECTION MAY BE THE WATER HEATERS. ADDITIONAL DETAILS FOR THIS PATIENT: THE PATIENT WAS INITIALLY CANNULATED FOR ECMO AFTER CARDIAC SURGERY. THE PATIENT WAS FOUND TO HAVE POSITIVE SPUTUM CULTURES FOR BURKHOLDERIA. THE PATIENT WAS ABLE TO COME OFF ECMO. THE PATIENT WAS DISCHARGED TO REHAB HOSPITAL. MANUFACTURER RESPONSE FOR HEATER/COOLER, MCH-1000 (PER SITE REPORTER): NO RESPONSE TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL DETAILS FOR THIS PATIENT: THE PATIENT WAS INITIALLY CANNULATED FOR ECMO AFTER CARDIAC SURGERY. THE PATIENT WAS FOUND TO HAVE POSITIVE SPUTUM CULTURES FOR BURKHOLDERIA. THE PATIENT WAS ABLE TO COME OFF ECMO. THE PATIENT WAS DISCHARGED TO REHAB HOSPITAL. MANUFACTURER RESPONSE FOR HEATER/COOLER, (B)(4) (PER SITE REPORTER): NO RESPONSE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348674 MCH-1000 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC CARDIOQUIP, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 22630 DA Hospitalization| R