BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY IV PLUM SET

    MDR report key: 1833395 · Received August 20, 2010

    Report

    Report Number
    1833395
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 20, 2010
    Manufacturer
    HOSPIRA WORLDWIDE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    NURSE WAS PRIMING IV PUMP SET AND OBSERVED LEAK FROM DISTAL Y-SITE. WHEN FILLED WITH FLUID, Y-SITE LEAKED FLUID; IT APPEARED TO BE CRACKED.DISCARDED THAT SET AND OBTAINED ANOTHER SET THAT DID NOT LEAK.NO ADVERSE PATIENT EVENT; REPORT IS MADE DUE TO POTENTIAL FOR SERIOUS ADVERSE EVENT - E.G. PATIENT INFECTION; MED ERROR DUE TO LOSS OF MEDICATION.====================== HEALTH PROFESSIONAL'S IMPRESSION============================================ MANUFACTURER RESPONSE FOR IV PUMP SET, PRIMARY IV PLUM SET======================LEFT MESSAGE FOR SALES REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY IV PLUM SET IV PUMP SET FPA HOSPIRA WORLDWIDE * 86072-5H

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR