BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2190080 · Received June 29, 2011

    Report

    Report Number
    9616066-2011-00345
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 2011
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BUT IT HAS NOT BEEN EVALUATED YET. A F/U REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK OCCURRING AT THE JUNCTION OF THE ELASTIC PORTION OF THE PRIMARY TUBING. THE PT RETURNED FROM THE BATHROOM AND NOTICED THERE WAS FLUID COMING OUT FROM THE BOTTOM OF THE IV PUMP. NONE OF THE FLUID HAD GOTTEN ON THE PT AND THE LEAK WAS CAUGHT SOON ENOUGH WHAT THE PT DID GET ALMOST ALL OF HIS ORDERED MEDICATIONS SO THERE WAS NO PT HARM. THE NURSE WAS ABLE TO VISUALIZE A HOLE IN THE ELASTIC PORTION OF THE TUBING JUST BELOW THE UPPER CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 2420-0500 11045987

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, S/N UNK| ALARIS PUMP MODULE, S/N UNK