BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BE-HLS 7050 #HLS SET ADVANCED 7.0

    MDR report key: 4608686 · Received March 12, 2015

    Report

    Report Number
    8010762-2015-00256
    Event Type
    Injury
    Date Received
    March 12, 2015
    Date of Event
    February 12, 2015
    Report Date
    February 13, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY REQUESTED THE DEVICE AND MORE DETAILED PRODUCT INFO. NEITHER HAS BEEN RECEIVED. ADDITIONAL INFO: THE PRODUCT MENTIONED UNDER SECTION D IS NOT DISTRIBUTED TO THE USA, BUT THE PRODUCT WITH CONTRIBUTING DESIGN FUNCTION TO THE AFFECTED COMPONENT (QUADROX-ID) IS REGISTERED UNDER 510(K): K101153. A SUPPLEMENTAL REPORT WILL BE SENT WHEN ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT ONE MINUTE AFTER CONNECTING THE TUBING-SET TO THE PT, AIR WAS NOTICED ON THE ARTERIAL OUTLET SIDE OF THE OXYGENATOR DUE TO A BUBBLE ALARM. THE CLINICAL PROFESSIONAL TRIED TO EVACUATE THE AIR USING A DISPOSABLE SYRINGE AND WAS ABLE TO EVACUATE ABOUT 60 ML OF AIR. HOWEVER, IT WAS NOT POSSIBLE TO EVACUATE ALL AIR FROM THE SYSTEM AND THE TUBING-SET WAS REPLACED. NO CONSEQUENCES TO THE PT HAV BEEN REPORTED AND THE TREATMENT WAS COMPLETED. NO VISIBLE DAMAGE TO THE TUBING-SET WAS NOTED. REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170052 BE-HLS 7050 #HLS SET ADVANCED 7.0 TUBING SET, HEART-LUNG BYPASS DTZ MAQUET CARDIOPULMONARY AG 70104.7753

    Patients

    Seq Age Sex Outcome Treatment
    1 Other