BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET HCU 30

    MDR report key: 4648078 · Received March 27, 2015

    Report

    Report Number
    8010762-2015-00308
    Event Type
    Other
    Date Received
    March 27, 2015
    Date of Event
    March 2, 2015
    Report Date
    March 2, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWC
    PMA / PMN Number
    K031544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THERE WERE TWO SIMILAR INCIDENTS REPORTED (REFERENCE # (B)(4) AND # (B)(4)) WITH TWO DIFFERENT DEVICES MAQUET CARDIOPULMONARY (B)(4) HAS ALREADY REQUESTED ONE OF THESE UNITS FOR INVESTIGATION. AS SOON AS THIS UNIT WILL HAVE BEEN ARRIVED AT MAQUET CARDIOPULMONARY (B)(4) AND THE INVESTIGATION WILL HAVE BEEN FINISHED WE WILL SEND YOU A FINAL REPORT. THE DESCRIBED ISSUE IS UNDER INVESTIGATION IN REFERENCE TO CAPA (B)(4). A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS ADDITIONAL INFO BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ON 11/30/2015, A FSCA WAS ISSUED REGARDING REVISED DECONTAMINATION PROCEDURES FOR HEATER AND HEATER-COOLER SYSTEMS FROM MAQUET. SINCE THE ISSUANCE OF THE 2015-11-30 FSCA, MAQUET HAS BECOME AWARE OF THE POSSIBILITY THAT THE RINSING PROCESS FOR THE HIGH LEVEL DISINFECTION WITH 5 PERCENT CHLORAMINE-T MAY NOT ADEQUATELY REMOVE ALL RESIDUAL DISINFECTANT. THEREFORE MAQUET IS PUTTING THE 2015-11-30 FSCA ON HOLD PENDING A RESOLUTION OF THIS ISSUE. IN ORDER TO ENSURE THE HIGHEST POSSIBLE PATIENT SAFETY, MAQUET HAS DECIDED TO PERFORM A FURTHER VALIDATION TO ENSURE SAFETY FACTORS ARE CHALLENGED BY THE DISINFECTION PROCESSES DELINEATED IN THE CORRESPONDING IFUS. THIS ADDITIONAL VALIDATION WILL CHALLENGE THE DISINFECTION PROCESS WITH REAL WORLD, HIGHLY CONTAMINATED DEVICES REPRESENTING THE WORST CASE POSSIBLE. THIS VALIDATION WILL BE PERFORMED AND COMPLETED: IN JANUARY 2016 FOR HCU 40; IN FEBRUARY 2016 FOR HCU 30 AND HU 35; IN MARCH 2016 FOR HCU 20. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ON 2015-11-30, FSCA 2015-11-30 WAS ISSUED REGARDING REVISED DECONTAMINATION PROCEDURES FOR HEATER AND HEATER-COOLER SYSTEMS FROM MAQUET. THIS FSCA WAS PUT ON HOLD A FEW DAYS LATER WITH FSCA 2015-12-10. A NEW FSCA WILL BE ISSUED AS SOON AS THE NEW DISINFECTION PROCEDURE IS PROPERLY VALIDATED AND CAN BE LAUNCHED. THE NEW IFU IS CURRENTLY UNDER REVISION AND WILL CONTAIN THE INSTRUCTIONS FOR THE NEW DISINFECTION PROCEDURE. DECEMBER 2016 IS ANTICIPATED MARKET LAUNCH OF THIS NEW DISINFECTION PROCEDURE.

    Description of Event or Problem · 1

    DESCRIPTION FROM THE CUSTOMER REPORT: "BACTERIAL GROWTH IN THE HCU30." (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS IS FOLLOW-UP 2 FOR THE INITIAL REPORT THAT WAS ORIGINALLY SUBMITTED AS 8010762-2015-00308 ON MARCH 27,2015 AND FOLLOW-UP 1 WHICH WAS SUBMITTED DECEMBER 23,2015. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205073 MAQUET HCU 30 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC MAQUET CARDIOPULMONARY AG 70103.4642

    Patients

    Seq Age Sex Outcome Treatment
    1 Other