BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SMARTSITE BLOOD ADMINISTRATION SET

    MDR report key: 1379603 · Received March 5, 2009

    Report

    Report Number
    9616066-2009-00140
    Event Type
    Malfunction
    Date Received
    March 5, 2009
    Report Date
    February 6, 2009
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    BRZ
    PMA / PMN Number
    K022209
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 03/04/2009. .

    Description of Event or Problem · 1

    DATE OF EVENT IS UNKNOWN. CUSTOMER REPORTED THAT AFTER SPIKING THE BLOOD OR SALINE BAG, THE TUBING SEPARATED FROM THE SPIKE ABOVE THE ROLLER CLAMP. NO PATIENT HARM REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SMARTSITE BLOOD ADMINISTRATION SET BRZ CARDINAL HEALTH ALARIS PRODUCTS 42080E 08065163

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK