BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3883767 · Received February 12, 2014

    Report

    Report Number
    9616066-2014-00115
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 8, 2014
    Report Date
    January 17, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION REQUESTED AND ALL AVAILABLE INFORMATION IS INCLUDED IN A SECTIONS A AND B. THIS REPORT WAS FILED BY THE MANUFACTURER. 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 SECONDARY SET INFUSION IS BACKING UP INTO THE PRIMARY TUBING. THE MAIN LINE WAS INFUSING SALINE; THE SECONDARY LINE WAS INFUSION ANTIBIOTICS. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. NO FURTHER PATIENT/EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94279 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2426-0007 13104326

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE, SN UNK| ALARIS PC UNIT, SN UNK| SECONDARY LINE, MFR/MODEL/LOT UNK