BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET WITH T-CONN. SL

    MDR report key: 3843497 · Received March 14, 2014

    Report

    Report Number
    9613251-2014-00061
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 27, 2014
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER. (B)(4). 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 DEVICE BREAKAGE; SUBSEQUENTLY, A LEAK WAS NOTED. THE TUBING SET WAS BEING USED TO DELIVER A PARENTERAL GLUCOSE-ELECTROLYTE SOLUTION OF GLUCOSE 10% (10G/100ML), PROTEIN 2.8G/100ML, DIVERGENT ELECTROLYTES, OR GLUCOSE 15% (15G/100ML), WITH A REPORTED VOLUME OF NOT MORE THAN 5ML, AT AN UNSPECIFIED RATE, VIA A PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT WHEN THE INFUSION WAS CHANGED, THE T-CONNECTOR OF THE TUBING SET WAS NOTED TO BE BROKEN. IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED. NO SPECIFIC DETAILS WERE PROVIDED. 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 ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154442 EXTENSION SET WITH T-CONN. SL UNK FPA HOSPIRA LTD. NA 25242NY

    Patients

    Seq Age Sex Outcome Treatment
    1 B BRAUN INFUSION SPACE, MFR BRAUN MEDICAL INC.