BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTXF SYM CONVP 2CLVE W 0.2 AEF

    MDR report key: 2180673 · Received May 5, 2011

    Report

    Report Number
    9615050-2011-00295
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 29, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED INABILITY TO PRIME THE DEVICE; RESULTING IN A DELAY IN THERAPY. IT WAS REPORTED THAT FOLLOWING AN INTRAMEDULLARY ROD PLACEMENT, THE PT WAS EXTUBATED AND MOVED FROM THE OPERATING ROOM TABLE TO THE RECOVERY ROOM CART. THE CUSTOMER CONTACT REPORTED THAT FOLLOWING EXTUBATION, THE PT WENT INTO A "FULL ARREST" IN THE OPERATING ROOM. REPORTEDLY, THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) ATTEMPTED TO PRIME THE TUBING SET TO DELIVER EPINEPHRINE 4MG, AT A RATE OF 0.2MCG/KG/MIN, VIA A SYMBIQ PUMP; HOWEVER, THE TUBING SET WOULD NOT PRIME. APPROX 5 MINS LATER, A REPLACEMENT TUBING SET WAS PRIMED AND THE THERAPY WAS INITIATED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PT WAS TRANSFERRED FROM THE OPERATING ROOM TO THE INTENSIVE CARE UNIT. ALTHOUGH THERE WAS A POTENTIAL FOR SERIOUS INJURY, THERE WERE NO REPORTED ADVERSE PT EFFECTS. 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 LTXF SYM CONVP 2CLVE W 0.2 AEF UNK FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1