BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVERTBL I.V. DUAL CHANNEL HSP

    MDR report key: 2181089 · Received July 7, 2011

    Report

    Report Number
    9615050-2011-00495
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 12, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPA AND HAS A 510K OF K933326. THE INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. 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 OF A CHEMOTHERAPEUTIC AGENT. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF TAXOL, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS REPORTED THAT A LEAK OF SOLUTION WAS NOTED AT THE FILTER OF THE TUBING SET. IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION CAME IN CONTACT WITH THE PATIENT'S SKIN. THE LEAK OF SOLUTION WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF ANY MEDICAL INTERVENTIONS WERE REQUIRED AND PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVERTBL I.V. DUAL CHANNEL HSP UNK FPA HOSPIRA COSTA RICA LTD. NA 831555H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM PUMP, LIST #UNK, SN UNK