BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOQUIP

    MDR report key: 6116548 · Received October 27, 2016

    Report

    Report Number
    3007899424-2016-00001
    Event Type
    Death
    Date Received
    October 27, 2016
    Date of Event
    September 9, 2016
    Report Date
    September 21, 2016
    Manufacturer
    CARDIOQUIP LLP
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L SERIAL NUMBERS: (B)(4). THE USER FACILITY DOES NOT CONSIDER THIS TO BE A DEVICE RELATED ADVERSE EVENT, REPORTING IT AS A PRODUCT PROBLEM. THE FACILITY CONDUCTED AN INVESTIGATION AND FOUND THAT THE HOSPITAL WATER SYSTEM WAS INFECTED WITH LEGIONELLA, AND THE WATER IN THE COOLER-HEATER DEVICES CONTAINED LEGIONELLA BECAUSE IT CAME FROM THE CONTAMINATED HOSPITAL WATER SUPPLY. THE INVESTIGATION FOUND NO LINK BETWEEN THE COOLER-HEATER DEVICES AND THE PT INFECTIONS. CARDIOQUIP SERVICE PERSONNEL PERFORMED ONSITE EVAL OF ALL COOLER-HEATER DEVICES (THE THREE LISTED ON THIS FORM, AND NINE OTHERS) AND FOUND NO EVIDENCE OF MALFUNCTION OR MISUSE. HOSPITAL PERSONNEL PERFORMED THE CLEANING AND DISINFECTION PROCEDURE, PER THE DEVICE IFU, AND REMOVED THE CONTAMINANTS FROM THE THREE DEVICES THAT HAD BEEN CONTAMINATED WITH LEGIONELLA FROM THE HOSPITAL WATER SUPPLY. CARDIOQUIP SERVICE PERSONNEL VERIFIED THAT THE HOSPITAL PERSONNEL PERFORMED THE CLEANING AND DISINFECTION PROCEDURES ADEQUATELY.

    Description of Event or Problem · 1

    TWO PTS WHO HAD SURGERY, LATER TESTED POSITIVE FOR LEGIONNAIRES' PNEUMONIA. DURING HOSPITAL'S INVESTIGATION INTO POTENTIAL SOURCE, 3 OPERATING ROOM COOLER-HEATER UNITS TESTED POSITIVE FOR LEGIONELLA BACTERIA. THERE HAS BEEN NO CONCLUSIVE EVIDENCE AT THIS TIME TO LINK THE PNEUMONIA TO THE EQUIPMENT. REF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714418 CARDIOQUIP MODULAR COOLER HEATER UNIT (MCH) DWC CARDIOQUIP LLP MCH-1000

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death