BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 11659597 · Received April 13, 2021

    Report

    Report Number
    3007899424-2021-00003
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    January 18, 2021
    Report Date
    June 3, 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

    MANUFACTURER RECIEVED USER FACILITY REPORT FROM THE FDA. PATIENT WAS INITALLY CANNULATED FOR ECMO AFTER CORNONARY VALVE REPLACEMENT SURGERY, FOUND TO HAVE POSITIVE BLOOD AND SPUTUM CULTURES FOR BURKHODLERIA.

    Additional Manufacturer Narrative · 1

    (B)(6) HOSPITAL SUBMITTED A USER FACILITY REPORT (B)(4). CARDIOQUIP FOLLOWED UP WITH BWH TO REQUEST THE DEVICE BE RETURNED TO CARDIOQUIP FOR INVESTIGATION. (B)(6) REQUESTED THE DEVICE BE HELD FOR INVESTIGATION BY BWH'S PERSONNEL AND HAVE CARDIOQUIP ASSIST IN DISASSEMBLING THE DEVICE. (B)(6) ALLOWED CARDIOQUIP'S PERSONNEL TO COME ONSITE AND VIEW THE DEVICE. CARDIOQUIP WAS NOT PERMITTED TO PERFORM ANY FORM OF VERIFICATION OR TESTING OF THE DEVICE TO CONFIRM INVOLVEMENT IN THE REPORT. (B)(6) INDICATED THEY WOULD PERFORM TESTING OF THE DEVICE TO DETERMINE CONTAMINATION AND THE RESULTS OF THE TESTING WOULD BE SUPPLIED TO CARDIOQUIP. (B)(6) PROVIDED A DESCRIPTION OF THE RESULTS BUT DID NOT PROVIDE THE QUANTITATIVE DATA THAT WOULD ALLOW FOR FURTHER INVESTIGATION AND EVALUATION OF THE EVENT. CARDIOQUIP CONTINUES TO MAINTAIN DIALOGUE WITH BWH REGARDING THIS EVENT.

    Description of Event or Problem · 1

    DESCRIBE THE EVENT OR PROBLEM: ADDITIONAL DETAILS FOR THIS PATIENT: THE PATIENT WAS INITIALLY CANNULATED FOR ECMO AFTER CORONARY VALVE REPLACEMENT SURGERY. THE PATIENT WAS FOUND TO HAVE POSITIVE BLOOD AND SPUTUM CULTURES FOR BURKHOLDERIA. THE PATIENT WAS ABLE TO COME OFF ECMO. THE PATIENT CONTINUES TO BE TREATED. THE ASSOCIATED USER FACILITY REPORT IS MDR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553848 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000 (M)

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Hospitalization| R