BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP 2CLV YSTE MACR

    MDR report key: 2193503 · Received July 21, 2011

    Report

    Report Number
    9613251-2011-00159
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 29, 2011
    Manufacturer
    HOSPIRA, LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. THE TUBING SET WAS TO BE USED TO DELIVER 1000ML OF 0.9% NORMAL SALINE BY GRAVITY. IT WAS REPORTED THAT THE NURSE PRIMED THE TUBING SET AND LEFT THE TUBING SET HANGING FROM THE IV POLE. IT WAS REPORTED THAT THE NURSE LEFT THE ROOM AND AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE RETURNED TO THE ROOM AND NOTED AN UNSPECIFIED VOLUME OF SOLUTION ON THE FLOOR. IT WAS REPORTED THAT THE TUBING SEPARATED FROM THE LEG OF THE PROXIMAL CLAVE Y-SITE. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP 2CLV YSTE MACR 80FPA FPA HOSPIRA, LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA