BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 17759988 · Received September 15, 2023

    Report

    Report Number
    3007899424-2023-00115
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    January 30, 2023
    Report Date
    February 5, 2024
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CARDIOQUIP RECEIVED A PHONE CALL FROM THE CUSTOMER ON 1/30/2023 REPORTING THAT A PATIENT TESTED POSITIVE FOR NTM AND HAS A STERNAL INFECTION. DURING A CONFERENCE CALL WITH MAYO CLINIC STAFF AND CARDIOQUIP, IT WAS DISCUSSED THAT THE HEATER-COOLER WAS OF CONCERN DUE TO KNOWN POTENTIAL FOR BACTERIAL CONTAMINATION IN THE HEATER-COOLER INDUSTRY. CARDIOQUIP SENT MAYO CLINIC AN HPC AND NTM SAMPLE TEST KIT, ON 2/1/2023, TO PROVIDE A QUANTITATIVE ASSESSMENT OF THEIR CARDIOQUIP HEATER-COOLER WATER QUALITY. PRELIMINARY LAB REPORTS SHOWED AN HPC COUNT OUTSIDE OF THE ACCEPTABLE LIMITS SPECIFIED FOR THE DEVICE BY CARDIOQUIP. BASED ON THESE RESULTS CARDIOQUIP RECOMMENDED TO MAYO CLINIC THAT THE DEVICE TESTED UNDERGO AN INTERNAL WATER PATHWAY REPLACEMENT. CARDIOQUIP PROVIDED A LOANER DEVICE, FOR MAYO CLINIC TO USE, WHILE THEIR WATER QUALITY WAS ASSESSED AND THE INVESTIGATION INTO POSSIBLE SOURCES OF CONTAMINATION OF THE DEVICE AND PATIENT WAS UNDERWAY. THE FINAL LAB REPORT WAS RECEIVED ON (B)(6) 2023 AND COMMUNICATED TO MAYO CLINIC. THE REPORT SHOWED LOW LEVELS OF UNSPECIFIED SPECIES OF NTM IN THE SUSPECT DEVICE. THE SOURCE OF THE CONTAMINATION HAS NOT BEEN IDENTIFIED BY EITHER CARDIOQUIP OR MAYO CLINIC AT THIS TIME. MAYO HAS STATED THAT THEY HAVE NOT CONCLUDED THAT THE HEATER-COOLER WAS THE CAUSE OF THE PATIENT INFECTION, RATHER, THAT THEY ARE FILING AN MDR AS A PRECAUTIONARY MEASURE UNTIL A ROOT CAUSE CAN BE IDENTIFIED. "BECAUSE OF THE ASSOCIATION OF THIS PARTICULAR ORGANISM, AS WELL AS USE OF HEATER COOLER DEVICE, AND STERNAL INFECTION, WE ARE SUBMITTING THIS POSSIBLE ADVERSE EVENT, AS SUGGESTED BY FDA ALERT IN 2021." FURTHER INVESTIGATIONS ARE BEING PERFORMED INTO POTENTIAL SOURCES OF CONTAMINATION THAT COULD IMPACT BOTH THE HEATER-COOLER AND THE PATIENT, SUCH AS A WATER SOURCE. AS OF THE DATE OF THIS REPORT, MAYO CLINIC HAS DECLINED THE INTERNAL WATER PATH REPLACEMENT ON THEIR CONTAMINATED DEVICE AND THE INVESTIGATION OF THIS EVENT IS STILL ONGOING TO DETERMINE THE ORIGIN/SOURCE OF THE DEVICE CONTAMINATION.

    Additional Manufacturer Narrative · 0

    DURING CARDIOQUIP'S INVESTIGATION OF THE PATIENT INFECTION INCIDENT, TESTING PERFORMED ON WATER SAMPLES TAKEN FROM THE CUSTOMER DEVICE FOUND THAT THE DEVICE WAS CONTAMINATED WITH MYCOBACTERIUM PARAGORDONAE. THE PATIENT INFECTION HAD BEEN IDENTIFIED AS CONTAINING MYCOBACTERIUM CHIMAERA. MYCOBACTERIUM CHIMAERA WAS NOT IDENTIFIED IN THE HEATER-COOLER. THEREFORE, THE CARDIOQUIP DEVICE IS NOT THE CAUSE OF THE PATIENT INFECTION. THE CUSTOMER BECAME UNRESPONSIVE TO OUR INQUIRIES AND TO OUR REQUESTS TO FURTHER INVESTIGATE THE SOURCE OF CONTAMINATION, OR TO SERVICE THE DEVICE IN ORDER TO REMEDIATE THE CONTAMINATION. DUE TO LACK OF INFORMATION, THE SOURCE OF THE CONTAMINATION REMAINS UNKNOWN, YET, IT IS MOST LIKELY THAT THE BACTERIA EMANATED FROM CONTAMINATED HOSPITAL INFRASTRUCTURE (E.G., WATER FILL LINES, SINKS, OR ICE MACHINES). CARDIOQUIP EVENTUALLY REPURCHASED THE DEVICE FROM THE CUSTOMER. FOLLOWING THIS REPURCHASE CARDIOQUIP HAS PERFORMED AN INTERNAL WATER PATHWAY PROCEDURE. FOLLOWING THE REPAIR, THE DEVICE WAS RETURNED TO SPECIFICATION AND IS FULLY FUNCTIONAL

    Description of Event or Problem · 0

    THE CUSTOMER'S PERFUSION SUPERVISOR CLAIMS THAT A PATIENT TESTED POSITIVE FOR NTM. THE PATIENT HAS A STERNAL INFECTION. THE PATIENT IS GOING THROUGH ANTIBIOTIC THERAPY AT THE MOMENT. THE CUSTOMER IS REQUESTING THIS UNIT TO GO THROUGH IWPR PROCEDURE.

    Description of Event or Problem · 0

    THE CUSTOMER'S PERFUSION SUPERVISOR CLAIMS THAT A PATIENT TESTED POSITIVE FOR NTM. THE PATIENT HAS A STERNAL INFECTION. THE PATIENT IS GOING THROUGH ANTIBIOTIC THERAPY AT THE MOMENT. THE CUSTOMER IS REQUESTING THIS UNIT TO GO THROUGH IWPR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303400 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown