BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMIN SET

    MDR report key: 3820779 · Received April 30, 2014

    Report

    Report Number
    9616066-2014-00454
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 23, 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

    MFR'S REPORT DATE: (B)(4) 2014. INTERNAL FILE NO: (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT AND NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE MALE LUER DISCONNECTED FROM A LOCKING CANNULA FEMALE LUER. BLOOD WAS LEAKING ONTO PT'S BE FROM THE LOCKING CANNULA THAT WAS STILL ATTACHED TO THE PICC LINE. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. NO FURTHER PT/EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259319 ALARIS PUMP MODULE ADMIN SET FPA CAREFUSION CORP 2123-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOCKING CANNULA: MODEL 9391-0300, THERAPY DATE UNK| PICC LINE: MFR/MODEL/LOT UNK