BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1080272 · Received July 22, 2008

    Report

    Report Number
    9615050-2008-00196
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 29, 2008
    Report Date
    July 2, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K953584
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A TUBING SEPARATION; SUBSEQUENTLY, BLOOD LOSS WAS NOTED. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF MAGNESIUM. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE TUBING SEPARATED FROM THE LEG OF THE CLAVE Y-SITE. AN UNSPECIFIED AMOUNT OF BLOOD LOSS WAS NOTED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION 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 631365H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK