BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP IV ADMINISTRATION SET

    MDR report key: 2004565 · Received February 25, 2011

    Report

    Report Number
    9616066-2011-00061
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Report Date
    December 7, 2010
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 02/25/2011. (B)(4). THE CUSTOMER'S EXPERIENCE OF SECONDARY INFUSION SOLUTION BACKING UP INTO THE PRIMARY SOLUTION WAS CONFIRMED IN CAREFUSION'S LAB. NO FAULT WAS FOUND WITH THE CHECK VALVE DURING THE SUPPLIER'S INVESTIGATION. THE CAUSE OF THE SECONDARY SOLUTION BACKING UP INTO THE PRIMARY SOLUTION CONTAINER WAS DUE TO A CHECK VALVE FAILURE. THE ROOT CAUSE OF THE CHECK VALVE FAILURE WAS NOT IDENTIFIED. THE LOT NUMBER WAS NOT IDENTIFIED. BASED ON THE SMARTSITE LASER NUMBER THIS DEVICE WAS MANUFACTURED BETWEEN 07/23/2010 AND 07/27/2010.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ON-GOING PROBLEM WITH SECONDARY INFUSIONS BACKING UP INTO THE PRIMARY. THE PRODUCT WAS ON A PT BUT NO PT HARM WAS REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP IV ADMINISTRATION SET FPA CAREFUSION CORP. 10012144 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 200ML HOSPIRA BAG WITH CIPROFLOXACIN| NON-ALARIS SECONDARY SET| 500ML BAXTER BAG OF 5% DEXTROSE| ALARIS SYSTEM PUMP MODULE: SERIAL NUMBER UNK| ALARIS SYSTEM PC UNIT: SERIAL NUMBER UNK