BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIM SYM SET 2 CL

    MDR report key: 3142765 · Received May 24, 2013

    Report

    Report Number
    9615050-2013-01377
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 3, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K103344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN REC'D. 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 LEAK. ON AN UNSPECIFIED DATE, THE OPTION-LOK 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 MORPHINE, AT AN UNSPECIFIED RATE, VIA A SYMBIQ PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM THE DISTAL END OF THE BACKCHECK VALVE OF THE TUBING SET. 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 ADD'L INFO WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231670 PRIM SYM SET 2 CL 80FPA FPA HOSPIRA COSTA RICA LTD. NA 260415H

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR