BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET-DUAL W/CON PP, CAP PORT & CLAVE

    MDR report key: 1032904 · Received April 23, 2008

    Report

    Report Number
    9615050-2008-00101
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 27, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K953584
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY IN CRITICAL THERAPY. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF PITOCIN IN LACTATED RINGER'S SOLUTION AT A RATE OF 125ML/HR VIA AN UNSPECIFIED PLUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, WHILE THE NURSE WAS ATTEMPTING TO ATTACH A 20ML SYRINGE TO THE CLAVE SECONDARY PORT ON THE CASSETTE, "THE TUBING TWISTED AND SPLIT. THE SOLUTION CONTAINER AND TUBING SET WERE REPLACED AND THE THERAPY WAS RESUMED. THE CUSTOMER CONTACT REPORTED A "CRITICAL MEDICATION DELAYED WHILE NEW SOLUTION HUNG WITH NEW TUBING. NEW MEDICATION BAG NEEDED TO BE MIXED, WHILE PT WAS HEMORRHAGING." THERE WERE NO REPORTED ADVERSE PT SEQUELAE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUMSET-DUAL W/CON PP, CAP PORT & CLAVE 80-FPA FPA HOSPIRA DE COSTA RICA LTD. NA 590305H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other