BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2221952 · Received August 17, 2011

    Report

    Report Number
    9616066-2011-00468
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Report Date
    July 29, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: (B)(4) 2011. UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED LEAK. THE CUSTOMER STATED THE SET WAS DISCARDED AND IS NOT AVAILABLE FOR FAILURE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SET LEAKING FROM ROUND SPOT ON FILTER. THE SET WAS INFUSING ON A PT AND THE NURSE FOUND A PUDDLE OF CHEMO (APPROX SEVERAL HUNDRED MLS) ON THE FLOOR BEHIND THE PT'S CHAIR. THERE WAS NO HARM TO THE PT OR STAFF AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 10010454 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK