BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SE PUMP ADMINISTRATION SET

    MDR report key: 2113613 · Received May 24, 2011

    Report

    Report Number
    9616066-2011-00249
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    April 26, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K931550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S COMPLAINT OF BLOOD BACK FLOW INTO TUBING COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION ALTHOUGH REQUESTED. THE CAUSE OF THE CUSTOMER'S REPORTED COMPLAINT IS UNK.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BACK FLOW OF BLOOD IN TUBING AFTER START OF IV INFUSION. CUSTOMER ALSO REPORTED IT LOOKS AS IF THE PUMP IS PULLING BACK FLUID. BLOOD BACK FLOW IS FROM PORT-A-CATH/CENTRAL LINE. CUSTOMER STATES THAT NO FURTHER PATIENT/EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SE PUMP ADMINISTRATION SET FPA CAREFUSION CORPORATION 72023E 10096049

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ALARIS SE INFUSION PUMP: SN (B)(4)