BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECONDARY IV SET-SL/CE (50/CS)

    MDR report key: 1723130 · Received June 8, 2010

    Report

    Report Number
    9615050-2010-00109
    Event Type
    Malfunction
    Date Received
    June 8, 2010
    Date of Event
    April 27, 2010
    Report Date
    May 10, 2010
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER 11877. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K052052. THIS REPORT REPRESENTS ALL THE INFORMATION 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 THAT WAS CONNECTED TO A PRIMARY PLUMSET AND WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, LEAKAGE OF SOLUTION WAS NOTED FROM THE CONNECTION TO THE PRIMARY PLUMSET. THE VOLUME OF SOLUTION THAT LEAKED WAS UNSPECIFIED. THE SPILL WAS CLEANED UP ACCORDING TO THE HOSPITAL'S POLICY. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS OR DELAY IN THERAPY CRITICAL FOR 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 SECONDARY IV SET-SL/CE (50/CS) UNK FPA HOSPIRA HOLDINGS DE COSTA RICA LTD. NA 851145G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PRIMARY PLUMSET: LIST #UNK, LOT #UNK