BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTXF SYM CNVTP 2CLVE

    MDR report key: 1934428 · Received November 23, 2010

    Report

    Report Number
    9615050-2010-00237
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 3, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED UNRESTRICTED FLOW. THE TUBING SET WAS USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF DIPRIVAN VIA A SYMBIQ PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE TUBING SET WAS DISCONNECTED FROM THE PT AND WAS REMOVED FROM THE PUMP. IT WAS REPORTED THAT AFTER THE TUBING SET WAS REMOVED FROM THE PUMP, FLUID CONTINUED TO FLOW. THE NURSE REPORTED THAT "NO MATTER WHICH WAY THE TOGGLE SWITCH WAS POSITIONED, THE FLUID WAS FREELY FLOWING." IT WAS REPORTED THAT THE NURSE HAD REMOVED THE TUBING SET AFTER THE CARRIAGE ON PUMP WAS PROPERLY OPEN. THE TUBING SET WAS REPLACED, BUT THE CUSTOMER CONTACT COULD SPECIFY IF THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS OR DELAYS IN THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTXF SYM CNVTP 2CLVE 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1