BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 14739225 · Received June 17, 2022

    Report

    Report Number
    3007899424-2022-00015
    Event Type
    Death
    Date Received
    June 17, 2022
    Date of Event
    March 1, 2021
    Report Date
    May 31, 2022
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER IS REPORTING THE FOLLOWING COMPLAINT AFTER A VOLUNTARY REVIEW OF ALL COMPLAINTS (REPORTABLE OR NOT) SINCE 2016. THIS REPORT IS BEING FILED NOW, AFTER BEING SCRUTINIZED UNDER A NEWLY REVISED RISK MATRIX, RECENTLY ADOPTED AFTER INSPECTION. A PATIENT DEVELOPED SERRATIA BACTEREMIA/SEPSIS AFTER SURGERY, LEADING TO MULTIORGAN FAILURE AND LATER EXPIRED. THE DEVICE WAS INSPECTED BY THE HOSPITAL, AND IT WAS DISCOVERED THAT THE TUBING INSIDE THE UNIT HAD A BUILDUP OF BIOFILM. DURING THE INVESTIGATION, THE BACTERIA FOUND IN THE DEVICE DID NOT MATCH THE BACTERIA THAT CAUSED THE PATIENT'S INFECTION. THE SOURCE OF THE BACTERIA IS STILL UNKNOWN; HOWEVER, DURING A DISCUSSION WITH A REPRESENTATIVE OF THE HOSPITAL, IT WAS MENTIONED THAT ROUTINE MAINTENANCE ACCORDING TO THE IFU WAS NOT BEING ADEQUATELY PERFORMED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE PATIENT DEVELOPED SERRATIA BACTEREMIA/SEPSIS AFTER CARDIAC AND RENAL TRANSPLANTATION, LEADING TO MULTIORGAN FAILURE AND TRANSITION TO COMFORT CARE AND LATER EXPIRED. AS PART OF THE FOLLOW-UP INVESTIGATION, THE HEATER-COOLER USED DURING THE SURGERY WAS EXAMINED. DURING THE INSPECTION, IT WAS NOTED THAT THE TUBING INSIDE THE MACHINE HAS EXTENSIVE BUILDUP OF BIOFILM. IT IS UNKNOWN WHETHER THIS CONTRIBUTED TO THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194219 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(R)

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death