BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3981194 · Received July 23, 2014

    Report

    Report Number
    9616066-2014-00708
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    July 8, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS DISCARDED AND NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SET WAS LEAKING HEPARIN FROM THE DISTAL PORT. "THE LEAKING WAS NOT NOTICED RIGHT AWAY, IT TOOK A FEW 'UNCHANGED' UNFRACTIONATED HEPARINS TO RECOGNIZE THERE WAS A PROBLEM WITH THE INFUSION". NO FURTHER PATIENT/EVENT INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432454 ALARIS PUMP MODULE ADMINISTRATION SET IV INFUSION SET FPA CAREFUSION CORPORATION 2426-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ALARIS PC UNIT, SERIAL NUMBER UNKNOWN,| ALARIS PUMP MODULE, SERIAL NUMBER UNKNOWN