BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTXF SYM CONVP CLVE

    MDR report key: 3182538 · Received June 14, 2013

    Report

    Report Number
    9615050-2013-01632
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 16, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT COMPLETE. 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 PINHOLE; SUBSEQUENTLY, A LEAK WAS NOTED. AT AN UNSPECIFIED TIME, THE TUBING SET WAS CONNECTED TO THE PT'S IV ACCESS SITE AND WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF VP-16, AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT APPROX 2 HOURS AFTER THE DELIVERY WAS STARTED, THE PT'S FATHER NOTIFIED THE NURSE THAT SOLUTION WAS LEAKING FROM THE TUBING. THE CUSTOMER CONTACT REPORTED THAT THE NURSE CLAMPED THE TUBING SET AND REPORTED THAT APPROX 10ML OF SOLUTION LEAKED FROM A PINHOLE AT THE CONNECTION OF THE DRIP CHAMBER AND THE TUBING OF THE TUBING SET. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THE PHYSICIAN WAS NOTIFIED AND DETERMINED THAT THE MEDICATION CONTAINER DID NOT NEED TO BE REPLACED. 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 INTERVENTIONS WERE REQUIRED. ON (B)(6) 2013, IT WAS REPORTED THE PT DEVELOPED AN UNSPECIFIED BLOOD STREAM INFECTION; HOWEVER, THE CUSTOMER CONTACT INDICATED THAT THIS WAS MOST LIKELY UNRELATED TO THE LEAKING SOLUTION. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272227 LTXF SYM CONVP CLVE 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR