BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LSLF EXT SET W CLV

    MDR report key: 2191061 · Received July 25, 2011

    Report

    Report Number
    9613251-2011-00161
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    June 27, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K941214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO 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 BLOOD VIA A RAPID INFUSER. THE CUSTOMER CONTACT INDICATED THAT THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO THE PT'S IV CATHETER. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS REPORTED THAT THE OPTION-LOK MALE ADAPTER DISCONNECTED FROM THE HUB OF THE IV CATHETER AND AN UNSPECIFIED VOLUME OF BLOOD LOSS WAS NOTED. AT THIS, IT WAS NOTED THAT THE PT IV SITE "DID NOT WORK" FOR AN UNSPECIFIED REASON AND A NEW IV SITE WAS ESTABLISHED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THE CUSTOMER CONTACT DID NOT REPORT A DELAY IN THERAPY; HOWEVER, THERE WAS NO CHANGE IN THE PT'S CLINICAL STATUS AND NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO 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 UNSPECIFIED IV CATHETER, LOT# ST1976217| MANUFACTURED BY JELCO