BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS PLUMSET-OL DUAL W/CLAVE & 0.2MICRON FILTER

    MDR report key: 1181090 · Received September 29, 2008

    Report

    Report Number
    9615050-2008-00285
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 12, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K953584
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO HAZARDOUS CONTAMINATION, THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION.

    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. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE CUSTOMER CONTACT REPORTED AN UNSPECIFIED VOLUME OF SOLUTION LEAKED ONTO THE PATIENT AND HEALTHCARE PROVIDER. IT WAS REPORTED THAT, TUBING LEAKED AT THE CONNECTION OF THE TUBING AND THE DISTAL END OF THE FILTER. THE SOLUTION THAT LEAKED WAS CLEANED UP, ACCORDING TO THE USER FACILITY'S PROTOCOL. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT OR THE HEALTHCARE PROFESSIONAL. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS PLUMSET-OL DUAL W/CLAVE & 0.2MICRON FILTER 80-FPA FPA HOSPIRA DE COSTA RICA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK