BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 280436 · Received May 31, 2000

    Report

    Report Number
    280436
    Event Type
    Injury
    Date Received
    May 31, 2000
    Date of Event
    April 25, 2000
    Report Date
    May 26, 2000
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    4/25/2000 WITHIN MINUTES OF STARTING HEMODIALYSIS PT. DEVELOPED ACUTE RESPIRATORY DISTRESS. DIALYSIS STOPPED. NON-RE-BREATHER MASK APPLIED, AMBU BAG, TRENDELENBERG POSITION. PT. AWAKE W/ SEVERE SHORTNESS OF BREATH, DIAPHORETIC. WITHIN MINUTES OF STOPPING DIALYSIS COLOR IMPROVED, SATS IMPROVED, & B/P UP. SUSPECTED AIR EMBOLISM. NO CRACKS NOTED IN HUB, NO AIR LEAK ALARM GOING OFF, NO AIR IN LINES. DIALYSIS CATH. REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD NIAGARA VAS-CATH HEMODIALYSIS CATH. MSD BARD ACCESS SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R