BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONV PIN IV FAT CLVE

    MDR report key: 2802446 · Received October 18, 2012

    Report

    Report Number
    9615050-2012-01253
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 19, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. THE CUSTOMER CONTACT IDENTIFIED TWO POSSIBLE LOT NUMBERS (PLOTS). THE POSSIBLE LOT NUMBERS ARE 151195H AND 151225H. 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 DEVICE BREAKAGE; SUBSEQUENTLY, A LEAK OF A CHEMOTHERAPEUTIC AGENT WAS NOTED. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION VIA A PLUM PUMP. AT AN UNSPECIFIED TIME, THE OPTION-LOK MALE ADAPTER OF A SECONDARY TUBING SET WAS CONNECTED TO THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE PRIMARY TUBING SET FOR A PIGGYBACK DELIVERY OF AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE CLAVE SECONDARY PORT BROKE OFF FROM THE CASSETTE OF THE PRIMARY TUBING SET. THE CUSTOMER CONTACT REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED. THE CUSTOMER CONTACT REPORTED UNSPECIFIED INJURIES; HOWEVER, NO SPECIFIC DETAILS HAVE BEEN PROVIDED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING THE SPECIFIC INJURY DETAILS, IF THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL, AND IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. HOSPIRA IS CONTINUING TO INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONV PIN IV FAT CLVE 80 FPA HOSPIRA COSTA RICA LTD. NA PLOTS5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUMSET: LIST #12538, LOT #061735H