BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SE ADMINISTRATION SET

    MDR report key: 2113611 · Received May 24, 2011

    Report

    Report Number
    9616066-2011-00250
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    February 15, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K931550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S REPORT OF CRACKS AND LEAKS FROM THE ACCUSLIDE WAS CONFIRMED. THE ROOT CAUSE OF THE LEAKS IN THE ACCUSLIDE BASE ASSEMBLY IS DUE TO ENVIRONMENTAL STRESS CRACKING CAUSED DURING THE STERILIZATION PROCESS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VISIBLE CRACKS AND LEAKING IN THE ACCUSLIDE FLOW REGULATOR. NO PT HARM WAS REPORTED. CUSTOMER STATES THAT NO FURTHER PATIENT/EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SE ADMINISTRATION SET FPA CAREFUSION CORPORATION 10013182 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN