BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 4080865 · Received August 26, 2014

    Report

    Report Number
    9616066-2014-00884
    Event Type
    Malfunction
    Date Received
    August 26, 2014
    Date of Event
    May 15, 2014
    Report Date
    July 29, 2014
    Manufacturer
    CAREFUSION COROPRATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. 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 AN IV SET MALE LUER BROKE OFF INTO A DISTAL SMARTSITE AND BLOOD LEAKED ONTO PATIENT'S BED. THE PATIENT WAS ADMITTED INTO THE PACU WITH IV FLUIDS INFUSING AND A LR INFUSION CONNECTED TO IV FLUIDS DISTAL SMARTSITE. THE NURSE DISCONNECTED THE LR MALE LUER FORM THE IV FLUIDS SMARTSITE AND BLOOD WAS NOTED TO BE BACKING UP AND LEAKING ONTO PATIENT'S BED. THE IV FLUIDS INFUSION WAS STOPPED AND A NEW IV SET AND IV FLUIDS BAG WAS HUNG. NO PATIENT HARM OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER PATIENT/EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515678 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION COROPRATION 2420-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, SN UNKNOWN, THERAPY DATE:| ALARIS PUMP MODULE, SN UNKNOWN, THERAPY DATE: