BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX

    MDR report key: 1080685 · Received July 11, 2008

    Report

    Report Number
    2087532-2008-00062
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 15, 2008
    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 9616240-2008-00036 AND MFR 9616240-2008-00037). HOT WATER WAS SPRAYED ONTO THE RIGHT LOWER FOREARM OF THE FACILITY'S NURSE WHILE THE DEVICE WAS UNDERGOING HEAT DISINFECTION. AT THAT MOMENT, THE NURSE WAS WIPING DOWN THE MACHINE WITH A DILUTE BLEACH SOLUTION. THE NURSE WAS DIAGNOSED WITH FIRST- DEGREE BURNS AND WAS TREATED AT THE EMERGENCY DEPT AT THE HOSPITAL. THE MACHINE WAS INSPECTED BY THE CLINIC'S BIOMEDICAL TECHNICAN WHO FOUND THAT THE CONCENTRATE TUBING AND THE TUBING CLIP HAD COME LOOSE FROM THE MALE CONNECTOR ASSEMBLY. HE REPLACED THE TUBING AND THE CLIP BACK ONTO THE MALE CONNECTOR ASSEMBLY. THE MACHINE WAS RETURNED TO SERVICE WITHOUT ANY FURTHER TUBE DISCONNECTION EVENT.

    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