BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS EXTENSION SET

    MDR report key: 2101951 · Received May 18, 2011

    Report

    Report Number
    9616066-2011-00244
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Report Date
    April 19, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K790108
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 05/18/2011. (B)(4). PRODUCT EVALUATED AND CUSTOMER'S EXPERIENCE OF A CRACKED MALE LUER AND LEAKING WAS NOT CONFIRMED. THE COMPONENT WAS INSPECTED AND NO ANOMALIES WERE FOUND. FUNCTIONAL TESTING WAS UNABLE TO DUPLICATE THE CUSTOMER'S ISSUE. THE ROOT CAUSE OF THE EVENT WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    PICU CLINICIAN REPORTED A CRACKED MALE LUER WHILE MILRINONE WAS INFUSING AND FOUND LEAKING AT THE CONNECTION. THE CRACK IS NOTED AT THE MALE LUER ALONG THE SCREW THREADS. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS EXTENSION SET FPA CAREFUSION CORP. 30914 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO ALARIS PC UNIT, SERIAL # UNK, LATE MARCH| ALARIS SYRINGE MODULE: SERIAL # UNK, LATE MARCH