BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTXF SYM CONVP CLVE

    MDR report key: 2110947 · Received April 25, 2011

    Report

    Report Number
    9615050-2011-00288
    Event Type
    Malfunction
    Date Received
    April 25, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    USER FACILITY MANDATORY MEDWATCH RECEIVED THAT STATED: "NURSE WENT TO HANG CHEMOTHERAPY ON PT AND NOTICED THE TUBING CLAVE WAS PUSHED IN. NURSE ATTEMPTED TO ATTACH TUBING TO SEE IF THE PLASTIC PIECE WOULD RETURN TO ITS POSITION BUT THIS WAS UNSUCCESSFUL. THIS WAS DISCUSSED WITH PHARMACIST AND AN ATTEMPT WAS MADE TO RUN CHEMOTHERAPY. THERE WAS IMMEDIATE DRIPPING SEEN OF 5 PERCENT DEXTROSE (D5W). THE TUBING WAS THEN CHANGED." UPON FURTHER QUERY, THE FOLLOWING INFO WAS PROVIDED THAT INDICATED THE CLAVE PORT REMAINED IN THE OPENED POSITION. THE PT WAS RECEIVING UNSPECIFIED MEDICATIONS PRIOR TO THE DELIVERY OF AN UNSPECIFIED CHEMOTHERAPY. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER 5% DEXTROSE IN WATER, AT AN UNSPECIFIED RATE, VIA A SYMBIQ PUMP. AT AN UNSPECIFIED TIME, THE OPTION-LOK MALE ADAPTER OF A SECOND TUBING SET WAS CONNECTED TO THE LOWER CLAVE Y-SITE OF THE PRIMARY TUBING SET TO DELIVER THE UNSPECIFIED MEDICATIONS, AT AN UNSPECIFIED RATE, VIA A SECOND SYMBIQ PUMP. IT WAS REPORTED THAT AFTER THE DELIVERY, THE SECOND TUBING SET WAS DISCONNECTED FROM THE CLAVE Y-SITE. AT THAT TIME, THE NURSE NOTED THAT THE SILICONE SLEEVE OF THE CLAVE Y-SITE REMAINED IN THE OPENED POSITION. A LEAK OF SOLUTION FROM THE CLAVE Y-SITE WAS NOTED. THE TUBING SET WAS REPLACED AND THE CHEMOTHERAPY DELIVERY WAS INITIATED. THERE WAS NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTXF SYM CONVP CLVE 80FRN FRN HOSPIRA COSTA RICA LTD. NA 931305H

    Patients

    Seq Age Sex Outcome Treatment
    1 SYMBIQ TUBING SET: LIST #16005, LOT #931305H