BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAL MEDICAL SUPPLY

    MDR report key: 21109 · Received January 24, 1995

    Report

    Report Number
    1051129-1994-00015
    Event Type
    Malfunction
    Date Received
    January 24, 1995
    Date of Event
    December 5, 1994
    Report Date
    December 28, 1994
    Manufacturer
    MANUFACTURAS ARRIOL C. POR A.
    Product Code
    FKB
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    ONE HR INTO PT'S HEMODIALYSIS TREATMENT, TUBING BEGAN TO HAVE AIR IN SYSTEM-ESPECIALLY ARTERIAL CHAMBER. UPON CLOSEER INSPECTION, END-USER NOTICED AIR COMING INTO TUBING SYSTEM AT CONNECTION ON ARTERIAL TUBINGWHERE THE BLOOD PUMP ROTATES. CONNECTION "CAME-APART" AND WAS ALLOWING AIR TO ENTER. ARTERIAL SIDE OF TUBING WAS CHANGED. T EXPERIENCED NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAL MEDICAL SUPPLY HEMODIALYSIS BLOOD TUBING FKB MANUFACTURAS ARRIOL C. POR A. NA A4F08

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR