BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 1881741 · Received October 11, 2010

    Report

    Report Number
    9615050-2010-00192
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 28, 2010
    Report Date
    September 17, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    Z-1045-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BACKFLOW OF FLUID FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY TUBING. THE SYMBIQ PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION VIA A SYMBIQ PUMP. AT AN UNSPECIFIED TIME, THE OPTION-LOK MALE ADAPTER OF A SECONDARY TUBING SET WAS CONNECTED TO THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF 50ML OF AN UNSPECIFIED MEDICATION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED THAT "THE PIGGYBACK EMPTIED THE BAG INTO THE MAIN LINE." THE TUBING SETS AND THE SOLUTION CONTAINERS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK FPA HOSPIRA COSTA RICA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR SYMBIQ PUMP: LIST #16026, (B)(4)| SECONDARY TUBING SET: LIST #14229, LOT #UNK