BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE IV ADMINISTRATION SET

    MDR report key: 2121167 · Received May 4, 2011

    Report

    Report Number
    9616066-2011-00180
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 10, 2011
    Report Date
    April 11, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: (B)(4) 2011. (B)(4). THE DEVICE HAS BEEN RECEIVED, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN DONE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT JUST AFTER HANGING AN INFUSION OF ATGAM, THE PATIENT NOTICED THE IV SET WAS LEAKING AT THE FILTER. THE INFUSION WAS SET TO RUN ON AN IV PUMP AS 86ML/HR FOR 6 HOURS. THE SET WAS CHANGED OUT AND THE INFUSION RESUMED. NO PATIENT HARM OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE IV ADMINISTRATION SET FPA CAREFUSION CORPORATION 10010454 10125971

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ALARIS PUMP MODULE: S/N UNKNOWN| ALARIS PC UNIT: S/N UNKNOWN