BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX

    MDR report key: 1080687 · Received July 11, 2008

    Report

    Report Number
    2087532-2008-00060
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    August 16, 2007
    Report Date
    June 4, 2008
    Manufacturer
    GAMBRO DASCO
    Product Code
    FII
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    GAMBRO RECEIVED A REPORT FROM A CUSTOMER WHO COMPLAINED THAT THREE NURSES SUSTAINED BURNS WHEN CONCENTRATE TUBING CAME OFF OF THE BLUE MALE CONCENTRATE CONNECTOR ASSEMBLY INSERTED INTO THE LOWER FRONT PANEL ON A PHOENIX MACHINE. THE EVENTS OCCURRED ON THREE DIFFERENT MACHINES WHICH WERE ALL EQUIPPED WITH THE SOFTWARE VERSION 3.34. ( FOR THE OTHER EVENTS REFER TO MDR 9616240-2008-00037 AND MDR 9616240-2008-00038). HOT WATER WAS SPRAYED ONTO THE LEG AND ARM OF THE FACILITY'S NURSE WHILE THE DEVICE WAS UNDERGOING HEAT DISINFECTION. AT THAT MOMENT, THE NURSE WAS WIPING THE EXTERNAL SURFACE OF THE MACHINE WITH A DILUTE BLEACH SOLUTION. ACCORDING TO THE NURSE SHE MAY HAVE PULLED ON THE BIOCARBONATE CONCENTRATE LINE IN THE PROCESS OF WIPING DOWN THE MACHINE. THE NURSE WAS DIAGNOSED WITH SECOND-DEGREE BURNS AND WAS TREATED AT THE EMERGENCY DEPT AT THE HOSPITAL. THE MACHINE WAS INSPECTED BY THE CLINIC'S BIOMEDICAL TECHNICIAN WHO FOUND THAT THE CONCENTRATE TUBING AND THE TUBING CLIP REMAINED IN THE BLUE MALE CONNECTOR ASSEMBLY AND THAT THE TUBING HAD BROKEN COMPLETELY OFF. THE TUBING WAS TRIMMED AND PLACED ONTO THE MALE CONNECTOR ASSEMBLY WITH THE TUBING CLIP PROPERLY PLACED ON THE LINE. THE MACHINE WAS RETURNED TO SERVICE AND NO FURTHER TUBE DISCONNECTION EVENTS HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX HEMODIALYSIS EQUIPMENT FII GAMBRO DASCO PHOENIX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention