BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2141389 · Received June 15, 2011

    Report

    Report Number
    9616066-2011-00323
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 7, 2011
    Report Date
    May 23, 2011
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BUT THE FAILURE INVESTIGATION HAS NOT YET BEGUN. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE PRODUCT HAS BEEN EVALUATED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK FROM TUBING WHILE PT WAS RECEIVING TOTAL PARENTAL NUTRITION (TPN) VIA AN ALARIS PUMP. NINETY MINUTES AFTER CHANGING THE PT'S TUBING, A LEAK WAS FOUND ON THE TUBING ABOVE SAFETY CLAMP. THE TUBING WAS CHANGED AND THE TPN WAS RESTARTED. NO PT HARM WAS REPORTED AND CUSTOMER STATES NO MEDICAL TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 2426-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, SN UNK| ALARIS PUMP MODULE, SN UNK