BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 11667483 · Received April 14, 2021

    Report

    Report Number
    3007899424-2021-00004
    Event Type
    Death
    Date Received
    April 14, 2021
    Date of Event
    March 15, 2021
    Report Date
    June 2, 2022
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. THE DEVICE WAS FOUND TO BE CONTAMINATED WITH THE SAME BACTERIA THAT CAUSED INFECTION IN THE PATIENT (BURKHOLDERIA). DUE TO LACK OF ACCESS TO THE DEVICE, AN INVESTIGATION ON OTHER SIMILAR DEVICES AT THE LOCATION HAD TO BE PERFORMED. THE TEST CAN CONCLUDE THAT ALL OF THE UNITS WOULD BE CONTAMINATED BUT UNABLE TO DECIDE ON WHETHER OR NOT THE DEVICE CAUSED THE ADVERSE EVENT. DUE TO THE LIMITATIONS OF THE INVESTIGATION PERFORMED AT THE FACILITY, CARDIOQUIP IS ALSO UNABLE TO RULE OUT THE POSSIBILITY OF A UNIFIED SOURCE OF CONTAMINATION FOR BOTH THE HEATER COOLER AND THE PATIENT, FOR EXAMPLE, A CONTAMINATED WATER SOURCE.

    Description of Event or Problem · 0

    THE CUSTOMER 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. A COMMON TRAIT AMONGST ALL WAS THE USE OF ECMO FOR CARDIOPULMONARY SUPPORT. THE CULTURE RESULTS SUGGEST THE SOURCE OF THE PATIENTS' INFECTION MAY BE THE WATER HEATERS.

    Additional Manufacturer Narrative · 1

    (B)(6) HOSPITAL (BWH) SUBMITTED A USER FACILITY REPORT (B)(4). CARDIOQUIP FOLLOWED UP WITH BWH TO REQUEST THE DEVICE BE RETURNED TO CARDIOQUIP FOR INVESTIGATION. BWH DID ALLOW CARDIOQUIP'S PERSONNEL TO COME ONSITE BUT PERSONNEL WERE NOT GIVEN ACCESS TO THE DEVICE. ADDITIONALLY, AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED TO CARDIOQUIP FOR INVESTIGATION AND ANY RESULTS FROM TESTING PERFORMED ON THE DEVICE BY BWH HAVE NOT BEEN SUPPLIED TO CARDIOQUIP. CARDIOQUIP IS IN CONTINUOUS DIALOGUE WITH BWH REGARDING THEIR INVESTIGATION AND POTENTIAL FOR THE DEVICE TO BE RETURNED TO CARDIOQUIP AT A LATER DATE.

    Description of Event or Problem · 1

    DESCRIBE THE EVENT OR PROBLEM: 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 STEPS TAKEN OR UNDERWAY INCLUDE: REVIEW OF ALL POSITIVE CULTURES FROM ALL ECMO PATIENTS FROM THE PAST YEAR TO IDENTIFY ANY OTHER[?][?] WITH BURKHOLDERIA OR CUPRIAVIDUS INFECTIONS. REVIEW OF ALL HOSPITALIZED PATIENTS WITH BURKHOLDERIA OR CUPRIAVIDUS INFECTIONS IN THE PAST YEAR TO IDENTIFY ANY NON-ECMO PATIENTS THAT MAY HAVE BEEN INVOLVED. SUBSPECIATION OF ALL BURKHOLDERIA ISOLATES FROM THE PAST YEAR TO IDENTIFY IF ANY WERE OF THE SAME SPACES AS THE CLUSTER STRAIN ("BURKHOLDERIA CONTAMINANS"). BIOAEROSOL SAMPLING ADJACENT TO AN OPERATIONAL ECMO WATER HEATER TO LOOK FOR AEROSOLIZATION OF BURKHOLDERIA AND/OR CUPRIAVIDUS. CULTURES OF WATER, FAUCET, AND DRAIN IN THE ECMO HEATER CLEANING AREA. ECMO WATER HEATER BURKHOLDERIA AND CUPRIAVIDUS SPECIMENS ARE BEING SENT FOR WHOLE GENOME SEQUENCING TO SEE IF THEY MATCH PATIENTS' ISOLATES. ECMO WATER HEATERS WILL BE PUT THROUGH THEIR CURRENT DISINFECTION CYCLE AND THEN RECULTURED TO ASSESS THE ADEQUACY OF THE PROCESS. THE ASSOCIATED USER FACILITY REPORT IS MDR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562883 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(M)

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Life Threatening| H| R| D| S