BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP PRIMARY PLUM PREPIERCED Y

    MDR report key: 2270571 · Received September 14, 2011

    Report

    Report Number
    9615050-2011-00712
    Event Type
    Malfunction
    Date Received
    September 14, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 24, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROGRESS. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80 FRN AND HAS A 510K OF K865060. THE INFO ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. 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 A LEAK OF A CHEMOTHERAPEUTIC AGENT. THE PRIMARY PLUMSET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF FARMORUBICIN, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT A LEAK SOLUTION WAS NOTED AT AN UNSPECIFIED LOCATION. THE PLUMSET WAS REPLACED AND THE THERAPY WAS RESUMED. 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 ADD'L INFO WAS PROVIDED INCLUDING DETAILS ON HOW THE SOLUTION THAT LEAKED WAS CLEANED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP PRIMARY PLUM PREPIERCED Y UNK FPA HOSPIRA COSTA RICA LTD. NA 021335H

    Patients

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