BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM LC OL CNVRTBL P

    MDR report key: 1881951 · Received October 12, 2010

    Report

    Report Number
    9615050-2010-00196
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 15, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K865060
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED DEVICE BREAKAGE; SUBSEQUENTLY, A LEAK OF A CHEMOTHERAPEUTIC AGENT WAS NOTED. AN UNSPECIFIED PRIMARY TUBING SET WAS BEING USED TO DELIVER SALINE. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE OPTION-LOK MALE ADAPTER OF THE PLUMSET WAS CONNECTED TO THE CLAVE PORT OF THE PRIMARY TUBING SET TO DELIVER AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. AFTER THE CHEMOTHERAPEUTIC AGENT WAS DELIVERED, THE NURSE REMOVED THE OPTION-LOK MALE ADAPTER FROM THE CLAVE PORT. IT WAS REPORTED AT THAT TIME, ¿THE END OF THE TUBING BROKE.¿ IT WAS REPORTED AN UNSPECIFIED VOLUME OF THE CHEMOTHERAPEUTIC AGENT SPILLED ONTO THE FLOOR AND AN UNSPECIFIED VOLUME OF BLOOD BACKED UP IN THE TUBING. THE SOLUTION THAT SPILLED WAS CLEANED UP ACCORDING TO THE USER FACILITY¿S PROTOCOL. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM LC OL CNVRTBL P 80FRN FRN HOSPIRA COSTA RICA LTD. NA 880625H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK