BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL150X60 DL CHN PLM

    MDR report key: 3383048 · Received September 11, 2013

    Report

    Report Number
    9615050-2013-02937
    Event Type
    Malfunction
    Date Received
    September 11, 2013
    Date of Event
    August 9, 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. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED SPLIT OF THE CYLINDER OF THE SOLUSET WERE IDENTIFIED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTING 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SPLIT IN THE SOLUSET OF THE TUBING SET; SUBSEQUENTLY, A LEAK WAS NOTED. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED VOLUME OF 10% DEXTROSE IN WATER, AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT DURING PRIMING OF THE TUBING SET PRIOR TO PATIENT USE, THE NURSE SQUEEZED THE SOLUSET OF THE TUBING SET. AT THIS TIME, IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION REPORTEDLY EXPLODED IN THE FACE OF THE NURSE. DURING VISUAL EXAMINATION AT THE USER FACILITY, IT WAS NOTED THAT THE SOLUSET WAS SPLIT, STRAIGHT DOWN. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE NURSE. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THERAPY WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456753 SOL150X60 DL CHN PLM 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1