BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH

    MDR report key: 261817 · Received February 9, 2000

    Report

    Report Number
    1423500-2000-00195
    Event Type
    Malfunction
    Date Received
    February 9, 2000
    Date of Event
    December 1, 1999
    Report Date
    January 10, 2000
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BAXTER DENMARK REPORTS A PT WITH A HOLE IN THE TRANSFER SET TUBING, NEAR THE PT ADAPTER. THIS HOLE RESULTED IN A LEAK. THE TRANSFER SET WAS THREE MONTHS OLD. THE PT WAS TREATED WITH THE FOLLOWING PROPHYLACTIC ANTIBIOTICS: 2 GR FORTUM AND 1 GR VANCOMYCIN. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH TRANSFER SET KDJ BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN