BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE IV ADMINISTRATION SET

    MDR report key: 2123511 · Received June 8, 2011

    Report

    Report Number
    9616066-2011-00307
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Report Date
    May 13, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K894842
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION COULD NOT BE PERFORMED. REPORTER INDICATED THAT THE DEVICE WAS DISCARDED. THE CAUSE OF THE REPORTED LEAK IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A DEFECTIVE SMARTSITE BLOOD SET TUBING. TUBING HAD A SPLIT IN IT AND SOAKED THE ALARIS PUMP. REPORTER STATES THIS IS THE ONLY INFORMATION RECEIVED. ATTEMPTS TO OBTAIN CLINICAL INFORMATION HAVE BEEN UNSUCCESSFUL. THERE HAS BEEN NO REPORT OF ANY PATIENT HARM OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE IV ADMINISTRATION SET FPA CAREFUSION CORPORATION 2477-0000 10116386

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ALARIS PC UNIT: SERIAL NUMBER UNKNOWN| ALARIS PUMP MODULE: SERIAL NUMBER UNKNOWN