BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP PRIMARY PLUM CLAVE Y

    MDR report key: 1934382 · Received November 23, 2010

    Report

    Report Number
    9615050-2010-00236
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 2, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K052052
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO HAZARDOUS CONTAMINATION, THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK OF A CHEMOTHERAPEUTIC AGENT. THE TUBING SET WAS CONNECTED TO A PICC LINE AND WAS BEING USED TO DELIVER NORMAL SALINE VIA A PLUM PUMP. AT AN UNSPECIFIED TIME, AN UNSPECIFIED SYRINGE CONTAINING AN UNSPECIFIED VOLUME OF EPIRUBICIN WAS CONNECTED TO THE CLAVE PORT OF THE CASSETTE ON THE TUBING SET. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT EPIRUBICIN WAS LEAKING FROM THE "BACK OF THE ADMINISTRATION SET." THE VOLUME OF SOLUTION THAT LEAKED WAS ESTIMATED TO BE "A COUPLE OF MLS." THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THERE WAS NO REPORTED ADVERSE PT EFFECT AND NO REPORTED DELAY IN THERAPY CRITICAL FOR THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP PRIMARY PLUM CLAVE Y 80FRN FRN HOSPIRA COSTA RICA LTD. NA 900465H

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR UNSPECIFIED SYRINGE, LIST# UNK, LOT# UNK