BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHOENIX

    MDR report key: 981473 · Received March 1, 2007

    Report

    Report Number
    2087532-2007-00059
    Event Type
    Other
    Date Received
    March 1, 2007
    Date of Event
    January 18, 2007
    Report Date
    February 1, 2007
    Manufacturer
    GAMBRO DASCO
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER 1.5 HOURS INTO A 3.5 HRS TREATMENT, THEY NOTICED A POOL OF BLOOD UNDER THE CHAIR. THE PT'S VASCULAR ACCESS WAS INSPECTED, AND IT WAS NOTED THAT THE VENOUS NEEDLE HAD PULLED OUT, BUT WAS STILL AFFIXED TO THE PT'S ARM WITH TAPE. THE PT WAS GIVEN 500 CC OF SALINE AND HEMOSTASIS WAS ACHIEVED AT THE PUNCTURE SITE. ANOTHER NEEDLE WAS INSERTED INTO THE ACCESS AND THE TREATMENT WAS RESUMED WITH NO FURTHER INCIDENT. THE PT WAS ASYMPTOMATIC THROUGHOUT THE EVENT. THE ESTIMATED BLOOD LOSS WAS 500CC'S THE PHYSICIAN WAS NOTIFIED AND THE PT'S ERYTHROPOIETIN DOSAGE WAS INCREASED. THE PT COMPLETED HIS PRESCRIBED TREATMENT AND WAS DISCHARGED FROM THE UNIT TO HOME. HE RETURNED FOR HIS REGULARLY SCHEDULED TREATMENT IN 2007, AND CONTINUES ON HIS DIALYSIS SCHEDULE WITH NO FURTHER ISSUES.

    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 64 YR Other