BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUSET 100X60W/CAI

    MDR report key: 3214712 · Received July 5, 2013

    Report

    Report Number
    9615050-2013-01912
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 7, 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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THE DEVICES WERE DISCARDED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. THE CUSTOMER CONTACT IDENTIFIED TWO POSSIBLE LOT NUMBERS (PLOTS). THE POSSIBLE LOT NUMBERS ARE 152425G AND 152435G. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED UNRESTRICTED FLOW WERE IDENTIFIED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE EVENT. THE COMMODITY ON THE INTERNATIONAL LIST NUMBER THAT MALFUNCTIONED IS COMPARABLE TO THE COMMODITY ON 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 UNRESTRICTED FLOW. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED MEDICATION AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT AFTER THE TUBING WAS CLAMPED WITH AN UNSPECIFIED CLAMP OF THE TUBING SET DURING PRIMING, UNRESTRICTED FLOW WAS NOTED. NO SPECIFIC DETAILS WERE PROVIDED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308037 SOLUSET 100X60W/CAI UNK FPA HOSPIRA COSTA RICA LTD. NA PLOTS5G

    Patients

    Seq Age Sex Outcome Treatment
    1 NA