BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLM TUBING SET

    MDR report key: 5102331 · Received September 24, 2015

    Report

    Report Number
    8010762-2015-01062
    Event Type
    Death
    Date Received
    September 24, 2015
    Date of Event
    August 28, 2015
    Report Date
    August 28, 2015
    Manufacturer
    MAQUET MEDICAL SYSTEMS, USA
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE PRODUCT MENTIONED IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-ID WHICH IS REGISTERED UNDER 510(K): K101153. (B)(4). THE DEVICE HAS BEEN REQUESTED FOR RETURN; BUT NOT YET RECEIVED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT WAS ON CARDIOHELP PROVIDING VENO-VENOUS SUPPORT USING TWO FEMORAL CANNULAE. RECEIVED TWO BUBBLE ALARMS; THE BUBBLE INTERVENTION WAS NOT BEING UTILIZED. AFTER THE SECOND ALARM A POCKET OF AIR IN THE POST MEMBRANE SIDE OF THE HLS WAS NOTED. IT WAS DESCRIBED AS STARTING ABOUT 1/2 INCH ABOVE THE DIA-CON CONNECTOR AND EXTENDING TO THE TOP OF THE APEX. SUPPORT PARAMETERS WERE REPORTED TO BE: FLOW: 0.8-1.2 LPMS, RPMS: 1905, PVEN -63 MMHG, PART 46 MMHG, PINT 46 MMHG. FLOW NEVER ABOVE 2 LITERS/MIN. AIR NEVER PULLED DOWN TO THE OUTLET. AN ATTEMPT TO REMOVE THE AIR WAS MADE BY REMOVING THE CAP ON THE HYDROPHOBIC FILTER; WITH NO CHANGE. AN ATTEMPT TO REMOVE THE AIR USING THE PIG-TAIL WAS ALSO NOT SUCCESSFUL. ONLY BLOOD WAS ASPIRATED; NOT AIR. IT WAS DETERMINED THAT THE PATIENT WAS BEING ADEQUATELY SUPPORTED AND THE CURRENT COURSE WOULD BE CONTINUED WITHOUT FURTHER ATTEMPT TO REMOVE THE AIR POCKET. THE NEXT MORNING, THE CUSTOMER REPORTED THAT THE SITUATION HAD NOT CHANGED AND THAT THEY FELT THAT THE PATIENT WAS WELL SUPPORTED. AFTER A FEW DAYS THE AIR WAS GONE; APPEARED TO SLOWLY DISSOLVE INTO THE BLOOD. TREATMENT WAS FROM 21:30 (B)(6) 2015 UNTIL 05:00 (B)(6) 2015; WHEN THE PATIENT EXPIRED. AS RELAYED BY THE CUSTOMER, THE DEATH WAS NOT AS A RESULT OF THE DEVICE, BUT DUE TO THE PATIENT'S CONDITION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631936 HLM TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET MEDICAL SYSTEMS, USA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| D