BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBORE GEMSTAR SET 96IN

    MDR report key: 3030893 · Received March 28, 2013

    Report

    Report Number
    9615050-2013-00557
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 7, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNK. THE CUSTOMER CONTACT IDENTIFIED A POSSIBLE LOT NUMBER (PLOTS). A REPRESENTATIVE DEVICE FROM POSSIBLE LOT NUMBER 227105H WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 LEAK. IT WAS REPORTED THAT THE SECURE LOCK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO THE PT'S IV ACCESS SITE AND WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF FLUOROURACIL (5FU), AT AN UNSPECIFIED RATE, VIA A GEMSTAR PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM AN UNSPECIFIED LOCATION ON THE PRESSURE ACTIVATED VALVE OF THE TUBING SET. THE CUSTOMER CONTACT REPORTED THAT THE TUBING SET WAS REPLACED AND THE THERAPY RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THE PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING IF THE SOLUTION LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127775 MICROBORE GEMSTAR SET 96IN 80FRN FRN HOSPIRA COSTA RICA LTD. NA PLOTS5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK