BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 13518665 · Received February 11, 2022

    Report

    Report Number
    3007899424-2022-00001
    Event Type
    Malfunction
    Date Received
    February 11, 2022
    Date of Event
    February 27, 2017
    Report Date
    June 15, 2022
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BACTERIAL CONTAMINATION REPORTED.

    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. IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE TESTED POSITIVE FOR A FEW THINGS HOWEVER THEY DID NOT PROVIDE ANY FURTHER CLARIFICATION AS TO WHAT THEY MEANT BY THIS. THE OPERATOR FAILED TO CLAMP OR VALVE THE LINE PRIOR TO DISCONNECTION. THE PRIMARY CAUSE WAS THE USE OF FLEXIBLE SURGICAL TUBING MATERIAL INSTEAD OF THE CARDIOQUIP HOSE KITS THAT WERE PROVIDED WITH THE DEVICE. SURGICAL TUBING SHOULD NOT BE USED FOR HCD WATER LINES, AS IT CREATES A SIGNIFICANT SPRAY HAZARD EVERY TIME IT IS PRESSURIZED.

    Description of Event or Problem · 0

    CUSTOMER DISCONNECTED A (B)(6) CONNECTOR FROM THE QUEST MPS WITHOUT FIRST VALVING, CLAMPING, OR DISCONNECTING THE VALVED CONNECTOR FROM THE MCH. WATER SPRAYED IN THE OR, INCLUDING ON THE PATIENT. CUSTOMER SAYS THAT WATER FROM THE MCH TESTED POSITIVE FOR "A FEW THINGS" BUT HAS NOT COMMUNICATED ANY SPECIFICS. CUSTOMER IS USING THEIR OWN HOSES, WITH NO INLINE VALVES. HOSES, MPS, AND BLANKET WERE PREVIOUSLY CONNECTED TO A 3T AND HAVE NOT BEEN SIMULTANEOUSLY DISINFECTED.

    Description of Event or Problem · 0

    CUSTOMER DISCONNECTED A HANSEN CONNECTOR FROM THE QUEST MPS WITHOUT FIRST VALVING, CLAMPING, OR DISCONNECTING THE VALVED CONNECTOR FROM THE MCH. WATER SPRAYED IN THE OR, INCLUDING ON THE PATIENT. CUSTOMER SAYS THAT WATER FROM THE MCH TESTED POSITIVE FOR "A FEW THINGS" BUT HAS NOT COMMUNICATED ANY SPECIFICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74835 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown