BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM LFS PRIM PMP

    MDR report key: 3905828 · Received May 29, 2014

    Report

    Report Number
    9615050-2014-03729
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE. 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. THE TUBING SET WAS BEING USED TO DELIVER 96MG OF PACLITAXEL. NO SPECIFIC DETAILS WERE PROVIDED. AT 1133, IT WAS REPORTED THAT THE DELIVERY STARTED. AT APPROXIMATELY 1205, A NURSE REPORTED THAT APPROXIMATELY 50ML OF SOLUTION LEAKED AT AN UNSPECIFIED LOCATION OF THE FILTER OF THE TUBING SET ONTO THE FLOOR. AT 1206, THE DELIVERY WAS STOPPED. IT WAS REPORTED THAT THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THE CUSTOMER CONTACT REPORTED THAT THE TUBING SET WAS REPLACED. AT 1300, THE THERAPY WAS RESUMED. THE CUSTOMER CONTACT REPORTED A DELAY IN THERAPY OF MORE THAN 50 MINUTES; HOWEVER, THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317277 PLM LFS PRIM PMP 80FRN FRN HOSPIRA COSTA RICA LTD. NA 311815H

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR