BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3172424 · Received June 5, 2013

    Report

    Report Number
    9615050-2013-01523
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 7, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. HOSPIRA HAS COMPLETED A FORMAL INVESTIGATION TO ADDRESS SIMILAR COMPLAINTS DUE TO SPIN COLLAR OPTION-LOK CONNECTION PROBLEMS WITH OTHER DEVICES WHICH RESULTED IN LEAKS, CRACKS, AND GENERAL CONNECTION EVENTS. BASED UPON THE INVESTIGATION RESULTS, HOSPIRA HAS IDENTIFIED THAT IT NEEDS TO MAKE DIMENSIONAL CHANGES TO THE SPIN COLLAR THAT WILL IMPROVE THE COMPLIANCE WITH ISO STANDARD ((B)(4)) AND INTERACTION WITH OTHER COMPONENTS. THE PLANNED IMPROVEMENTS WILL OPTIMIZE THE DESIGN OF THE THREAD, TAPER AND TAPER PROTRUSION OF THE OPTION-LOK TO MINIMIZE IDENTIFIED FAILURE MODES AND RESULTANT COMPLAINTS. 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. THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO A NEEDLELESS VALVE CONNECTOR AND WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AT AN UNSPECIFIED TIME, A SECONDARY TUBING SET WAS CONNECTED TO THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE PRIMARY TUBING SET FOR A PIGGYBACK DELIVERY OF CYTOXAN 1200MG/250ML, WITH A VOLUME TO BE DELIVERED OF 310ML, FOR A DURATION OF 30 MINUTES. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. IT WAS REPORTED THAT 21 MINUTES AFTER THE DELIVERY WAS STARTED, THE PT REPORTED THAT HER CLOTHES WERE WET. AT THIS TIME, THE NURSE NOTED THAT SOLUTION LEAKED FROM THE LUER CONNECTION OF THE OPTION-LOK MALE ADAPTER AND THE NEEDLELESS VALVE CONNECTOR. THE CUSTOMER CONTACT REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION CAME INTO CONTACT WITH THE PT'S SKIN AND CLOTHING. IT WAS REPORTED THAT THE NURSE NOTED THAT THE LUER CONNECTION WAS LOOSE AND TIGHTENED THE LUER CONNECTION. THE THERAPY WAS RESUMED. IT WAS REPORTED THAT THE PT'S SKIN WAS WASHED AND THE PT'S CLOTHES WERE CHANGED. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. 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
    249585 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR MAXPLUS CLEAR CONNECTOR, LIST #(B)(4),| MFR CAREFUSION