BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS PLUM PRIMARREGULAR PUMP SET 5000 - XL

    MDR report key: 3111649 · Received May 7, 2013

    Report

    Report Number
    9615050-2013-01059
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 HOLE IN THE TUBING SET; SUBSEQUENTLY, A LEAK WAS NOTED. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED VOLUME OF AN UNSPECIFIED MEDICATION. IT WAS REPORTED THAT DURING PRIMING OF THE TUBING SET PRIOR TO PT USE, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM A HOLE AT AN UNSPECIFIED LOCATION OF THE TUBING SET. THE TUBING SET WAS REPLACED AND THE THERAPY WS INITIATED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199870 LS PLUM PRIMARREGULAR PUMP SET 5000 - XL 80FRN FRN HOSPIRA COSTA RICA LTD. NA 131605H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA