BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM LS PRIM. 225 CM CLAVE PORT DISTA

    MDR report key: 3022751 · Received March 22, 2013

    Report

    Report Number
    9615050-2013-00466
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 21, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THE DEVICE WAS DISCARDED. HOSPIRA HAS COMPLETED A FORMAL INVESTIGATION TO ADDRESS THE ISSUE OF LEAKS OF THE CLAVE SECONDARY PORT. BASED ON THE INVESTIGATION RESULTS, IT WAS DETERMINED THAT THE LEAKS WERE DUE TO THE DESIGN OF CLAVE PORT THAT IS DIRECTLY BONDED TO THE SECONDARY PORT OF THE CASSETTE. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPA AND HAS A 510K OF K030002. 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 PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED IV SOLUTION, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AT AN UNSPECIFIED TIME, THE MALE ADAPTER OF A SECONDARY TUBING SET WAS CONNECTED TO THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE TUBING SET FOR A PIGGYBACK DELIVERY OF 500ML OF AN UNSPECIFIED CONCENTRATION OF DOCETAXEL, AT AN UNSPECIFIED RATE. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. IT WAS REPORTED THAT 15 MINUTES AFTER THE DELIVERY WAS STARTED, THE CUSTOMER CONTACT REPORTED THAT 15ML OF SOLUTION LEAKED AT AN UNSPECIFIED LOCATION FROM THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE TUBING SET. THE CUSTOMER CONTACT REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION CAME IN CONTACT WITH PATIENT'S HAND. REPORTEDLY, INFILTRATION INTO THE TISSUE AND SWELLING OF THE PATIENT'S HAND WAS NOTED. THE PATIENT WAS TREATED WITH AN UNSPECIFIED CONCENTRATION OF AN UNSPECIFIED STEROID CREAM. THE TUBING SET WAS REPLACED AND THE THERAPY RESUMED. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER'S FACILITY'S PROTOCOL. THERE WAS NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120833 PLUM LS PRIM. 225 CM CLAVE PORT DISTA UNK FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention SECONDARY TUBING SET: LIST #0F056, LOT # UNK