BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF CONV PP OL 2 C

    MDR report key: 1395002 · Received April 8, 2009

    Report

    Report Number
    9615050-2009-00079
    Event Type
    Malfunction
    Date Received
    April 8, 2009
    Date of Event
    March 6, 2009
    Report Date
    March 13, 2009
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K052722
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVIC IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED NO FLOW. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE. IT WAS REPORTED THAT AN UNSPECIFIED SECONDARY TUBING SET WAS CONNECTED TO THE UPPER CLAVE Y-SITE FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED CONCENTRATION OF ZOMETA AT A RATE OF 300ML/HR. AFTER DELIVERY OF THE SECONDARY SOLUTION WAS COMPLETED, IT WAS REPORTED THAT THE PRIMARY TUBING SET DID NOT FLOW. THE PRIMARY TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. 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 LF CONV PP OL 2 C 80FPA FPA HOSPIRA COSTA RICA LTD. NA 712205H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT# UNK| UNSPECIFIED SECONDARY TUBING SET: LIST# Z2791