BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS PLUM PRIMARREGULAR PUMP SET 5000 - XL

    MDR report key: 1854613 · Received September 9, 2010

    Report

    Report Number
    9615050-2010-00165
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    July 6, 2010
    Report Date
    August 12, 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
    CO
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. 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 INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED UNRESTRICTED FLOW. THE TUBING SET WAS TO BE USED FOR DELIVERY OF AN UNSPECIFIED VOLUME OF NORMAL SALINE. IT WAS REPORTED THAT DURING PRIMING OF THE TUBING SET PRIOR TO PATIENT USE, THE PHARMACIST NOTED UNRESTRICTED FLOW. IT WAS REPORTED, "THE SALINE SOLUTION WAS FILTERING THROUGH THE VALVE." THE "VALVE" WAS DESCRIBED AS "DAMAGED." THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. THERE WAS NO REPORTED DELAY IN CRITICAL THERAPY. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING SPECIFIC "DAMAGE" DETAILS AND CLARIFICATION OF THE REPORTED "VALVE" COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS PLUM PRIMARREGULAR PUMP SET 5000 - XL 80FRN FRN HOSPIRA COSTA RICA LTD. NA 870025H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA