BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LTX FR CONV SOLST

    MDR report key: 2506053 · Received March 22, 2012

    Report

    Report Number
    9615050-2012-00283
    Event Type
    Malfunction
    Date Received
    March 22, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K063239
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED NO FLOW. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF LACTATED RINGERS SOLUTION VIA GRAVITY. ON AN UNSPECIFIED DATE, THE TUBING SET WAS PRIMED AND THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO THE PT¿S IV ACCESS SITE. AT AN UNSPECIFIED TIME, THE DELIVERY OF SOLUTION WAS STARTED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE ANESTHESIOLOGIST NOTED NO FLOW IN THE DRIP CHAMBER DISTAL TO THE SOLUSET OF THE TUBING SET. IT WAS REPORTED THAT THE DRIP CHAMBER OF THE TUBING SET WAS EMPTY AND AN UNSPECIFIED VOLUME OF AIR WAS NOTED IN THE TUBING SET. IT WAS REPORTED THE FLOAT VALVE OF THE SOLUSET WAS IN THE CLOSED POSITION; HOWEVER, AN UNSPECIFIED VOLUME OF SOLUTION REMAINED IN THE SOLUSET. IT WAS REPORTED THAT THE DRIP CHAMBER WAS SQUEEZED AND THE FLOAT VALVE OPENED AND SOLUTION ENTERED THE DRIP CHAMBER. IT WAS REPORTED THAT THE AIR WAS REMOVED FROM THE TUBING SET AND THE THERAPY WAS RESUMED. NO AIR WAS DELIVERED TO THE PT. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL 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