BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LSLF EXT SET W CLV

    MDR report key: 2103790 · Received May 24, 2011

    Report

    Report Number
    9613251-2011-00108
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 25, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. A REPRESENTATIVE DEVICE FROM A DIFFERENT LOT 01093NS WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DISCONNECTION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF LACTATED RINGER'S SOLUTION VIA GRAVITY DURING AN UNSPECIFIED SURGICAL PROCEDURE. THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO AN INSYTE AUTOGUARD 20 GAUGE IV CATHETER. THE CUSTOMER CONTACT REPORTED THE PATIENT'S ARMS WERE TUCKED UNDER A SHEET. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, AN UNSPECIFIED VOLUME OF BLOOD WAS NOTED LEAKING ONTO THE SHEET. IT WAS REPORTED THAT THE OPTION-LOK MALE ADAPTER OF THE TUBING SET DISCONNECTED FROM THE IV CATHETER. IT WAS REPORTED THAT THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS RECONNECTED TO THE CATHETER AND THE CONNECTION WAS RECONNECTED AND TIGHTENED. THE THERAPY WAS RESUMED. A HEMOGLOBIN WAS DRAWN WITH A RESULT OF 8.0GM/DL. THE CUSTOMER CONTACT REPORTED THAT PATIENT WAS TREATED WITH "AT LEAST ONE UNIT" OF PACKED RED BLOOD CELLS AND THE SURGICAL PROCEDURE WAS COMPLETED AS PLANNED. AFTER THE PROCEDURE WAS COMPLETE, THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT WAS TRANSFERRED TO AN INPATIENT ROOM AS PLANNED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LSLF EXT SET W CLV 80FPK FPK HOSPIRA LTD. NA UNKNS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT #1054734, MANUFACTURED BY BECTON DICKINSON| INSYTE AUTOGUARD IV CATHETER: LIST #381434