BEUDAMED
    FDA Adverse Event Other Summary report: N

    MACQUET HCU20 DEVICE

    MDR report key: 4963115 · Received July 31, 2015

    Report

    Report Number
    8010762-2015-00860
    Event Type
    Other
    Date Received
    July 31, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 16, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED FROM MAQUET (B)(4) 11/10/2015 THE INFORMATION, THAT THE CUSTOMER COULD NOT DISCLOSE THE TEST RESULTS. ON 11/30/2015, FSCA WAS ISSUED REGARDING REVISED DECONTAMINATION PROCEDURES FOR HEATER AND HEATER-COOLER SYSTEMS FROM MAQUET. SINCE THE ISSUANCE OF THE 11/30/2015 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 11/30/2015 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 ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ON NOVEMBER 30, 2015, 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. MARKET LAUNCH OF THE NEW DISINFECTION PROCEDURE IS (B)(4).

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY HAS NOT YET RECEIVED ANY LAB RESULTS WHICH CONFIRM THE BACTERIAL CONTAMINATION. THIS ISSUE IS UNDER FURTHER INVESTIGATION WITH REGARD TO CAPA (B)(4). A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DESCRIPTION FROM THE CUSTOMER: "HCU20 CONTAMINATION OF THE WATER WITH MYCOBACTERIUM CHYMERA." (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4). THIS IS A FOLLOW-UP 2 REPORT FOR THE INITIAL THAT WAS ORIGINALLY SUBMITTED AS 8010762-2015-00860 ON JULY 31, 2015 AND FOLLOW-UP 1 THAT WAS SUBMITTED DECEMBER 23, 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499112 MACQUET HCU20 DEVICE CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other