BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1813186 · Received August 19, 2010

    Report

    Report Number
    9616066-2010-00237
    Event Type
    Malfunction
    Date Received
    August 19, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 18, 2010
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATED AND CUSTOMER'S COMPLAINT OF LEAKING AT THE VALVE WAS VERIFIED. THE CAUSE OF THE LEAKING WAS IDENTIFIED AS TWO HOLES ON THE RUBBER PISTON OF THE SMARTSITE VALVE. THE CAUSE OF THE HOLES COULD NOT BE IDENTIFIED. THE LOT NUMBER WAS NOT IDENTIFIED. BASED ON THE SMARTSITE LASER NUMBER, THE MANUFACTURING DATABASE WAS REVIEWED; NO QUALITY ISSUES WERE NOTED DURING PRODUCTION BUILD PERIOD OF THIS MODEL FOR THE FAILURE MODE REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LEAKING AT VALVE INJECTION SITE. CUSTOMER IS QUESTIONING IF SOMEONE TRIED TO PUT A NEEDLE THROUGH THE VALVE OR IF THE VALVE WAS DEFECTIVE. NO PT HARM REPORTED. NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 2420-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK