BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LSLF EXT SET W CLV

    MDR report key: 2152495 · Received June 27, 2011

    Report

    Report Number
    9613251-2011-00133
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF CONTRAST MEDIUM, AT AN UNSPECIFIED RATE VIA A POWER INJECTOR. THE MALE ADAPTER OF AN UNSPECIFIED POWER INJECTOR TUBING WAS CONNECTED TO THE CLAVE PORT OF THE TUBING SET. IT WAS REPORTED THAT IMMEDIATELY AFTER THE DELIVERY OF CONTRAST WAS STARTED, THE TUBING SEPARATED FROM THE OPTION-LOK MALE ADAPTER OF THE TUBING SET. A LEAK OF SOLUTION AND AN UNSPECIFIED VOLUME OF BLOOD LOSS WERE NOTED. THE TUBING SET WAS REPLACED AND THE PROCEDURE WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL 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 01091NS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED POWER INJECTOR TUBING: MFR UNK