BEUDAMED
    FDA Adverse Event Other Summary report: N

    THORACENTESIS KIT

    MDR report key: 3690890 · Received March 14, 2014

    Report

    Report Number
    MW5035047
    Event Type
    Other
    Date Received
    March 14, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 13, 2014
    Manufacturer
    CAREFUSION
    Product Code
    GCB
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WE RECENTLY SWITCHED TO A NEW THORACENTESIS KIT, THE CAREFUSION THORACENTESIS KIT. OUR PREVIOUS KIT AND ALL OTHERS I HAVE USED CAN ONLY BE HOOKED UP IN ONE DIRECTION AS THEY HAVE DIFFERENT CONNECTORS FOR THE TUBING WHICH IS TO GO TO THE BAG FROM THAT WHICH IS TO GO TO THE PATIENT AND CATHETER. IN THIS KIT, BOTH ENDS OF THE TUBING HAVE AN IDENTICAL LUER LOCK ADAPTER. THE ONLY DIFFERENCE BETWEEN THE LIMBS OF THE TUBING IS THAT ONE IS LONGER THAN THE OTHER. THEY HAVE NO OTHER DISCERNIBLE DIFFERENCES. WHEN THE TUBING OF THIS CAREFUSION THORACENTESIS KIT IS HOOKED UP BACKWARDS, IT IS POSSIBLE TO PUSH AIR INTO THE PLEURAL SPACE, FOR EXAMPLE, IF BOTH TUBING ENDS ARE HOOKED UP (IN A BACKWARDS FASHION) ALL THE AIR IN THE DRAINAGE BAG AND TUBING CAN BE PUSHED INTO THE PLEURAL SPACE IN THE WRONG DIRECTION. IF THE SYSTEM IS HOOKED UP BACKWARDS AND THE TUBING TO THE BAG IS LOOSE OR IS NOT HOOKED UP, UNLIMITED QUANTITIES OF AIR CAN BE PUSHED INTO THE PLEURAL SPACE. I DEMONSTRATED THIS ON TWO SEPARATE KITS TO THE CAREFUSION REP TO SHOW IT WAS NOT AN ISOLATED KIT PROBLEM. THE VALVES APPEAR TO BE ONE WAY FOR FLUID BUT TWO WAY FOR AIR AND THE SYSTEM ALLOWS YOU TO PUSH AIR INTO THE PLEURAL SPACE WHEN HOOKED UP BACKWARDS, POTENTIALLY RESULTING IN A TENSION PNEUMOTHORAX. IN THIS PATIENT CASE, IT WAS IDENTIFIED AFTER 10ML OF AIR WERE INSTILLED AND THE KIT WAS REVERSED (TO THE APPROPRIATE DIRECTION) AND THE PLEURAL FLUID AND AIR WERE EVACUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152329 THORACENTESIS KIT THORACENTESIS KIT GCB CAREFUSION CAREFUSION PARA/THORA KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR