BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 11667536 · Received April 14, 2021

    Report

    Report Number
    3007899424-2021-00005
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    November 5, 2020
    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 FDA. PATIENT WAS CANNULATED FOR ECHMO AFTER LUNG TRANSPLANT. PATIENT WAS FOUND TO HAVE POSITIVE BLOOD AND SPUTUM CULTURES FOR BURKHOLDERIA.

    Additional Manufacturer Narrative · 1

    (B)(6) SUBMITTED A USER FACILITY REPORT (B)(4). CARDIOQUIP FOLLOWED UP WITH BWH TO REQUEST THE DEVICE BE RETURNED TO CARDIOQUIP FOR INVESTIGATION. (B)(6) 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 (B)(6) 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: ADDITIONAL DETAILS FOR THIS PATIENT: THE PATIENT WAS INITIALLY CANNULATED FOR ECMO AFTER LUNG TRANSPLANT. THE PATIENT WAS FOUND TO HAVE POSITIVE BLOOD AND SPUTUM CULTURES RESPECTIVELY 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
    564574 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000 (M)

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Hospitalization| R