BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRIMARY PLUM SET WITH CONV PIN, SEC CAP PORT, 1 CL

    MDR report key: 567697 · Received January 25, 2005

    Report

    Report Number
    9615050-2005-00015
    Event Type
    Death
    Date Received
    January 25, 2005
    Date of Event
    November 11, 2004
    Report Date
    December 28, 2004
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    USER FACILITY MANDATORY MEDWATCH RECEIVED, WHICH STATED THE FOLLOWING: "AFTER A PT CARE ASSISTANT TURNED THE PT ONTO THEIR SIDE, THE PT'S IV TUBING DISLODGED. THE PT CARE ASSISTANT PROCEEDED TO RE-CONNECT THE TUBING TO WHAT THEY THOUGHT WAS THE APPROPRIATE PORT. THE IV TUBING WAS ACTUALLY RECONNECTED TO THE PT'S TRACH CUFF INFLATION PORT. APPROX A LITTLE OVER ONE HOUR LATER, THE PT RESPIRATORY ARRESTED AND CODE BLUE WAS INITIATED. APPROXIMATELY 20 CC'S OF FLUID HAD INFUSED INTO THE TRACH CUFF. THE CODE WAS UNSUCCESSFUL." UPON FURTHER QUERY THE FOLLOWING INFO WAS PROVIDED: THE CUSTOMER CONTACT INDICATED THAT THE PT WAS RECEIVING AN INFUSION OF LACTATED RINGERS AT A RATE OF 75 ML/HR. AT APPROXIMATELY 1830, THE NURSE WAS CALLED TO THE PT'S ROOM BECAUSE THE IV PUMP WAS ALARMING WITH A UNSPECIFIED MESSAGE. AT THAT TIME, THE CODE BLUE WAS CALLED. THE CUSTOMER CONTACT STATED THAT THEY WERE OF THE OPINION THAT AN OPERATOR ERROR IN CONNECTING THE DEVICE CAUSED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY PLUM SET WITH CONV PIN, SEC CAP PORT, 1 CL ADMINISTRATION SET FPA HOSPIRA DE COSTA RICA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death KIMBERLY-CLARK.| PLUM 1.6 PUMP, LIST #2507,| BALLARD TRACH CARE, T-PIECE, 14 FR, MFR BY