BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP IV ADMINISTRATION SET

    MDR report key: 2004623 · Received February 25, 2011

    Report

    Report Number
    9616066-2011-00060
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Report Date
    December 7, 2010
    Manufacturer
    CAREFUSION CORPORATION
    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

    (B)(4). THE CUSTOMER'S EXPERIENCE OF SECONDARY INFUSION SOLUTION BACKING UP INTO THE PRIMARY SOLUTIONS 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 (B)(4) 2010 AND (B)(4) 2010. THE LOT NUMBER WAS NOT IDENTIFIED. BASED ON THE SMARTSITE LASER NUMBER, THIS SAMPLE'S EXPIRATION DATE WAS EITHER AUGUST 01, 2013 OR SEPTEMBER 1, 2013.

    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 PATIENT BUT NO PATIENT HARM WAS REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN 250ML BAXTER BAG WITH CYTARABINE| ALARIS SYSTEM PUMP MODULE: SERIAL # UNK| 500ML BAXTER BAG OF 0.9% SODIUM CHLORIDE| NON-AARIS SECONDARY SET| ALARIS SYSTEM PC UNIT: SERIAL # UNK