BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUMSET 2 CLAVE 272CM NDEHP

    MDR report key: 2741620 · Received August 31, 2012

    Report

    Report Number
    9615050-2012-01010
    Event Type
    Malfunction
    Date Received
    August 31, 2012
    Date of Event
    January 1, 2012
    Report Date
    June 29, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K052052
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. 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 80FRN AND HAS A 510K OF K865060. 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 DEVICE BREAKAGE; SUBSEQUENTLY, A LEAK OF A CHEMOTHERAPEUTIC AGENT WAS NOTED. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE TUBING SET BROKE OFF AND AN UNSPECIFIED VOLUME OF CHEMOTHERAPEUTIC AGENT LEAKED. THE CUSTOMER CONTACT REPORTED THAT AN UNSPECIFIED VOLUME OF THE CHEMOTHERAPEUTIC AGENT CAME IN CONTACT WITH AN UNSPECIFIED LOCATION ON THE NURSE. THE CUSTOMER CONTACT REPORTED THAT THE NURSE WAS WEARING PERSONAL PROTECTIVE EQUIPMENT. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE NURSE. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED, INCLUDING IF THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY PLUMSET 2 CLAVE 272CM NDEHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA 081615H

    Patients

    Seq Age Sex Outcome Treatment
    1