BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1972633 · Received January 19, 2011

    Report

    Report Number
    9616066-2011-00008
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Report Date
    October 22, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 01/19/2011. (B)(4). PRODUCT EVALUATED AND THE CUSTOMER'S EXPERIENCE OF LEAKING WHERE THE FILTER FITS IN LINE WITH THE SET WAS CONFIRMED. THE LEAKING IS AT THE ENGAGEMENT BETWEEN THE TUBING SLEEVE AND THE INLET PORT OF THE 0.2 MICRON FILTER. THE ROOT CAUSE WAS IDENTIFIED AS A MFG ISSUE DUE TO INSUFFICIENT SOLVENT. THE CAUSE OF THE INSUFFICIENT SOLVENT WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SET LEAKED AT THE BONDING SITE WHERE FILTER FITS IN LINE WITH THE ADMINISTRATION SET. NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 11609481 10086108

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, SERIAL NUMBER UNKNOWN| ALARIS PUMP MODULE, SERIAL NUMBER UNKNOWN