BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBORE GEMSTAR SET 96IN

    MDR report key: 3061259 · Received April 10, 2013

    Report

    Report Number
    9615050-2013-00672
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 21, 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 DEVICE 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 SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF DOXORUBICIN, AT AN UNSPECIFIED RATE, FOR A DURATION OF 3 DAYS, VIA A GEMSTAR PUMP. IT WAS REPORTED THAT AFTER THE DELIVERY WAS COMPLETE THE HOMECARE PT RETURNED TO THE USER FACILITY. IT WAS REPORTED THAT WHILE DISCONNECTING THE TUBING SET FROM THE PT'S IV ACCESS SITE, THE TUBING SEPARATED FROM THE PIERCING PIN OF THE TUBING SET. IT WAS REPORTED THAT THE THERAPY WAS COMPLETE; THEREFORE, THE TUBING SET WAS NOT REPLACED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150048 MICROBORE GEMSTAR SET 96IN 80FRN FRN HOSPIRA COSTA RICA LTD. NA 221705H

    Patients

    Seq Age Sex Outcome Treatment
    1