BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE LUMEN PICC 2.6FRENCH 12 CM

    MDR report key: 2839452 · Received October 26, 2012

    Report

    Report Number
    2839452
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    July 26, 2012
    Report Date
    September 28, 2012
    Manufacturer
    MEDCOMP
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE WHITE PORT OF A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) WAS SUPPLYING THE PATIENT WITH AN INFUSION OF SEDATION MEDICATION AND MILRONONE DROPS, WHILE THE RED LUMEN WAS SUPPLYING A BLOOD TRANSFUSION. THE INTRAVENOUS (IV) TEAM WAS CONSULTED TO ASSESS THE (PICC) LINE DUE TO THE BEDSIDE NURSE REPORTING THAT DURING THE BLOOD TRANSFUSION, THE BLOOD WAS INFUSING THE RED LUMEN AND ALSO THE WHITE LUMEN CAUSING THE INTRAVENOUS FLUIDS (IVF) IN THE TUBING TO APPEAR BLOOD TINGED IN COLOR.WHEN THE TRANSFUSION WAS COMPLETED THE WHITE PORT FLUSHED EASILY WITH NO SIGNS OF LEAKING, HOWEVER THE RED PORT WAS FLUSHED AND THEN BLOOD ASPIRATED BACK. DURING BLOOD ASPIRATION, IT WAS NOTED BLOOD FLUSHING INTO THE EXTENSION SET OF THE WHITE LUMEN. THERE WAS LIKELY A LEAK BETWEEN THE LUMENS OF THE PICC LINE.THE IV TEAM RECOMMENDED NO FURTHER USE OF THE RED LUMEN. THE WHITE LUMEN WAS USED FOR MILIRONONE DROPS UNTIL PICC CAN BE REWIRED, 2 PERIPHERAL INTRAVENOUS LINES (PIV) WERE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE LUMEN PICC 2.6FRENCH 12 CM CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 LJS MEDCOMP * MBHT

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO