BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LTX FR CONV SOLST

    MDR report key: 2021358 · Received February 8, 2011

    Report

    Report Number
    9615050-2011-00065
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 10, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K063239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICES WERE DISCARDED. THE DEVICES WERE NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICES COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF AIR IN THE TUBING. THE SOLUSETS WERE BEING USED TO DELIVER UNSPECIFIED VOLUMES OF LACTATED RINGER'S SOLUTION. IT WAS REPORTED THAT AFTER UNSPECIFIED LENGTHS OF TIME IN USE, THE ANESTHESIA STAFF NOTED AIR BUBBLES IN THE SOLUSETS AND IN THE TUBINGS BELOW THE SOLUSETS. IT WAS REPORTED THAT THE CLINICIANS EITHER REPLACED THE SOLUSETS OR WITHDREW THE AIR FROM THE TUBINGS WITH SYRINGES DISTAL TO THE SOLUSETS. NO AIR WAS DELIVERED TO THE PTS. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS IN THERAPIES CRITICAL FOR THESE PTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS LTX FR CONV SOLST 80FPK FPK HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1