BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL150X60 DL CHN PLM

    MDR report key: 3383011 · Received September 11, 2013

    Report

    Report Number
    9615050-2013-02945
    Event Type
    Malfunction
    Date Received
    September 11, 2013
    Date of Event
    January 1, 2013
    Report Date
    August 12, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. 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 SPLIT IN THE SOLUSET. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED VOLUME OF AN UNSPECIFIED SOLUTION, AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT DURING PRIMING PRIOR TO PATIENT USE, THE NURSE SQUEEZED THE SOLUSET. AT THIS TIME, IT WAS REPORTED THAT THE SOLUSET SPLIT STRAIGHT DOWN. ALTHOUGH THERE WAS POTENTIAL FOR A LEAK, NO LEAK WAS REPORTED. NO SPECIFIC DETAILS WERE PROVIDED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THERAPY WAS INITIATED OR IF SOLUTION LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455528 SOL150X60 DL CHN PLM 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA