BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYGENATOR, CARDIOPULMONARY BYPASS

    MDR report key: 5735819 · Received June 20, 2016

    Report

    Report Number
    8010762-2016-00396
    Event Type
    Injury
    Date Received
    June 20, 2016
    Date of Event
    May 30, 2016
    Report Date
    June 2, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTM
    PMA / PMN Number
    K090689
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS REQUESTED FOR MANUFACTURER'S LABORATORY INVESTIGATION BUT WAS NOT YET RETURNED. THE INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE OXYGENATOR WAS CLEANED AND A CIRCUIT WITH AN HL20 WAS CREATED. A FLUID LEAKAGE OUT OF THE DE-AIRING MEMBRANE WAS CONFIRMED. BASED ON THIS THE FAILURE "BUBBLES SPOUTING FROM THE DE-AIRING PORT" COULD BE CONFIRMED. THE FAILURE IS KNOWN TO MAQUET CARDIOPULMONARY AND WAS THOROUGHLY INVESTIGATED BY (B)(4). CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN ESTABLISHED IN (B)(4) BASED ON THE ROOT CAUSE ANALYSIS. DEVELOPMENT AND IMPLEMENTATION OF AN OPTICAL INSPECTION OF THE (B)(4) (MEMBRANE). DEVELOPMENT AND IMPLEMENTATION OF A NEW PUNCHING PROCESS. IMPROVEMENT OF THE PACKAGING OF THE MEMBRANE ROLLS AT THE SUPPLIER. PREVENTION OF PRESSURES ABOVE THE TOLERANCE IN PRESSURE TEST UNITS (REVISION/ENHANCEMENT OF BASIC OPERATING PROCEDURES). FULL FURTHER INVESTIGATION AND ALL OTHER ACTIONS AND THE EFFECTIVENESS THEREOF, WILL BE CARRIED OUT AS PART OF THE CAPA INVESTIGATION.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER: THE INCIDENT OCCURRED DURING THE DEVICE WAS IN USE FOR THE SURGERY ON (B)(6) 2016, 60 MIN. AFTER THE EXTRACORPOREAL CIRCULATION STARTED: IT WAS OBSERVED THAT THE BUBBLES WERE SPOUTING FROM THE GAS INLET PORT AT UPPER PART OF THE OXYGENATOR THE CUSTOMER FOUND THE REDDISH LIQUID, WHICH MAY HAVE BEEN SPOUTING FROM THE PORT, ON THE FLOOR UNDER THE OXYGENATOR. IT WAS OBSERVED THAT THE REDDISH LIQUID ADHERED TO THE BODY OF THE OXYGENATOR, AROUND THE AREA OF THE PORT. (B)(4) (DISTRIBUTOR) WAS CONTACTED (11:49AM?) CONFIRMED THAT THERE IS NO PROBLEM ON THE GAS EXCHANGE ABILITY. TOLD THE CUSTOMER TO CLOSE THE CAP OF THE PORT IN QUESTION. (B)(4) VISITED THE HOSPITAL. CONFIRMED THAT THE PROBLEM SOLVED AFTER THE CUSTOMER CLOSED THE CAP. (B)(4)

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390989 OXYGENATOR, CARDIOPULMONARY BYPASS FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE DTM MAQUET CARDIOPULMONARY AG HMO 51000-J 70110881

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention