BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LF NITRO PUMP SET W/LIGHT PROTECTIVE TUB

    MDR report key: 3171885 · Received June 7, 2013

    Report

    Report Number
    9615050-2013-01563
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 9, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER. (B)(4). THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A MISSING COMPONENT; SUBSEQUENTLY, A LEAK WAS NOTED. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE, AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT DURING PRIMING OF THE TUBING SET, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM THE SECONDARY PORT ON THE CASSETTE OF THE TUBING SET. THE CUSTOMER CONTACT REPORTED THAT THE NONVENTED CAP WAS MISSING FROM THE SECONDARY PORT ON THE CASSETTE OF THE TUBING SET. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253794 LF NITRO PUMP SET W/LIGHT PROTECTIVE TUB UNK FPA HOSPIRA COSTA RICA LTD. NA 150365H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA