BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF MB EXT SET CLAVE LSC T

    MDR report key: 2910056 · Received November 19, 2012

    Report

    Report Number
    9613251-2012-00225
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Date of Event
    September 6, 2012
    Report Date
    October 25, 2012
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    UPON FURTHER QUERY, THE CUSTOMER CONTACT REPORTED A SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION. THE CUSTOMER CONTACT REPORTED THAT AFTER THE PT WAS REPOSITIONED ONTO THE PT'S BACK FOLLOWING THE PROCEDURE, THE TUBING HAD SEPARATED AT AN UNSPECIFIED LOCATION OF THE TUBING SET. IT WAS REPORTED THAT UNSPECIFIED VOLUME OF SOLUTION LEAKED AND AN UNSPECIFIED VOLUME OF BLOOD LOSS WAS NOTED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTION WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS LF MB EXT SET CLAVE LSC T 80FPA FPA HOSPIRA LTD. NA 71075NS

    Patients

    Seq Age Sex Outcome Treatment
    1