BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2140555 · Received June 15, 2011

    Report

    Report Number
    9616066-2011-00319
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Report Date
    May 18, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BUT THE EVAL HAS NOT BEEN COMPLETED. A F/U REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK AT TUBING ATTACHMENT TO FILTER. LINES HAD BEEN PRIMED WITH SALINE. LEAK WAS NOTICED AFTER PRIMING. CHEMOTHERAPY HAD NOT YET BEEN ADMINISTERED.

    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 ALARIS PUMP MODULE, S/N UNK| ALARIS PC UNIT, S/N UNK