BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODUEL ADMIN SET

    MDR report key: 3941487 · Received April 16, 2014

    Report

    Report Number
    9616066-2014-00388
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 12, 2014
    Report Date
    April 1, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE MALE LUER DISCONNECTED FROM THE LUER LOCKING CANNULA FEMALE LUER AND BLOOD IV FLUIDS LEAKED ON TO PT'S BED. CUSTOMER REPORTS THE PT WAS VERY AGITATED THROUGHOUT THE NIGHT AND MOVING AROUND A LOT OF WHICH WAS PROBABLY A CONTRIBUTING FACTOR TO THE DISCONNECTION. EVENT OCCURRED IN THE PEDIATRIC UNIT. THERE WAS NO PT HARM OR MEDICAL INTERVENTION. NO FURTHER PT/EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232166 ALARIS PUMP MODUEL ADMIN SET FPA CAREFUSION CORP 2123-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MODEL 9391-0200, LOT UNK| VERSASAFE SLIPT SEPTUM PLASTIC CANNULA,