BEUDAMED
    FDA Adverse Event Other Summary report: N

    SET ADMINISTRATION

    MDR report key: 1258163 · Received December 3, 2008

    Report

    Report Number
    2016493-2008-00206
    Event Type
    Other
    Date Received
    December 3, 2008
    Report Date
    November 17, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FPA
    PMA / PMN Number
    K022209
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED FLUID COMING FROM BOTH PRIMARY BAG AND THE SECONDARY BAG DURING AN INFUSION OF VANCOMYCIN. DATE OF EVENT UNKNOWN. PRIMARY SET. SECONDARY SET. CUSTOMER REPORTS THAT INFUSIONS ARE TAKING LONGER THAN EXPECTED; "HOURS FOR SOME DRUGS TO INFUSE INSTEAD OF 30-60 MINUTES". NO PATIENT HARM REPORTED. PRODUCT RETURN REQUESTED. FOLLOW UP REPORT WILL BE FILED WHEN INVESTIGATION IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET ADMINISTRATION FPA CARDINAL HEALTH ALARIS PRODUCTS 2426-0500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other