BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTXF SYM CNVTP 2CLVE

    MDR report key: 1881700 · Received October 11, 2010

    Report

    Report Number
    9615050-2010-00194
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 4, 2010
    Report Date
    September 17, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    Z-1048-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNK. A DEVICE FROM ONE OF TWO POSSIBLE LOT NUMBERS (720945H AND 911585H) IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BACKFLOW OF FLUID FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY SOLUTION CONTAINER. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER 0.9% SODIUM CHLORIDE AT AN UNSPECIFIED RATE VIA A SYMBIQ PUMP. AT AN UNSPECIFIED TIME, THE MALE ADAPTER OF A SECONDARY TUBING SET WAS CONNECTED TO THE PROXIMAL CLAVE Y-SITE ON THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF CIPRO 400MG/200ML AT A RATE OF 200ML/HR AND A DURATION OF ONE HR. THE PRIMARY SOLUTION CONTAINER WAS LOWERED BELOW THE SECONDARY SOLUTION CONTAINER. IT WAS REPORTED THAT AFTER THE CIPRO DELIVERY WAS STARTED, THE NURSE NOTED BACKFLOW OF SOLUTION INTO THE PRIMARY SOLUTION CONTAINER. THE SECONDARY SOLUTION CONTAINER WAS REPORTED TO BE HALF EMPTY AND THE "VOLUME OF THE PRIMARY SOLUTION CONTAINER HAD RISEN." THE TUBING SETS AND THE SOLUTION CONTAINERS WERE REPLACED AND THE THERAPIES WERE RESUMED ON THE OTHER CHANNEL OF THE PUMP. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. DURING TESTING AT THE USER FACILITY, BACKFLOW WAS NOTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION 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 SECONDARY TUBING SET: LIST #UNK, LOT #UNK| SYMBIQ PUMP: LIST #16027, (B)(4)