BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY PLUMSET-OL DUAL W/CON PP

    MDR report key: 235664 · Received August 12, 1999

    Report

    Report Number
    6000096-1999-00044
    Event Type
    Injury
    Date Received
    August 12, 1999
    Date of Event
    March 17, 1999
    Report Date
    March 17, 1999
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM ABBOTT INTERNATIONAL AFFILIATE (ABBOTT POLAND) THAT STATES: "AIR BUBBLES IN DISTAL LINE IN NUMBERS AND VOLUMES NOT ACCEPTED FOR CENTRAL VENOUS DELIVERY IN CHILDREN." NO INFO REGARDING THE PT OR TUBING SET UP WAS AVAILABLE. THE SET WAS IN USE INFUSING A TPN SOLUTION AT 10ML/H WITH A VOLUME OF 250ML. THE ONLY OTHER INFO RECEIVED STATES, "A CHILD EXPERIENCED AN AIR EMBOLISM THAT WAS CONFIRMED BY RADIOLOGY. THE AGE, SEX, MEDICAL HISTORY AND PT TREATMENT WAS UNK. THE PT REPORTEDLY "RECOVERED." MULTIPLE REQUESTS HAVE BEEN MADE TO THE POLAND AFFILIATE TO OBTAIN FURTHER INFO. NO REPSONSE HAS BEEN RECEIVED. IF ANY SIGNIFICANT INFO RELEVANT TO THIS INCIDENT BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A MEDWATCH FOLLOW-UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY PLUMSET-OL DUAL W/CON PP ADMINISTRATION SET FPA ABBOTT LABORATORIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other