BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1935484 · Received December 15, 2010

    Report

    Report Number
    9616066-2010-00371
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    CAREFUSION CORP
    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

    (B)(4). PRODUCT EVALUATED AND CUSTOMER'S REPORT OF A LEAK WAS CONFIRMED. FUNCTIONAL TESTING CONFIRMED A LEAK FROM A HOLE IN THE DRIP CHAMBER. THE ROOT CAUSE OF THE HOLE WAS IDENTIFIED AS A SUPPLIER ISSUE DURING MFG. THE LOT NUMBER WAS NOT IDENTIFIED. BASED UPON THE SMARTSITE VALVE LASER NUMBER, SET WAS MFG BETWEEN 07/09/2010 AND 07/12/2010 WITH AN EXPIRATION DATE OF 07/2015.

    Description of Event or Problem · 1

    CUSTOMER REPORTED IV SET LEAKED DURING AN INFUSION OF CHEMOTHERAPY MEDICATION. THE CHEMOTHERAPY LEAKED ONTO THE PT'S ARM AND BEDDING. THE PT'S ARM WAS CLEANSED WITH SOAP AND WATER AND THE BEDDING WAS CHANGED. NO PT OR STAFF HARM REPORTED. NO ADDITIONAL EVENT INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 10015048 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SERIAL # UNK| ALARIS PUMP MODULE: SERIAL # UNK