BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 1749299 · Received July 1, 2010

    Report

    Report Number
    9615050-2010-00122
    Event Type
    Malfunction
    Date Received
    July 1, 2010
    Date of Event
    May 30, 2010
    Report Date
    June 4, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    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. THE CUSTOMER CONTACT COULD NOT PROVIDE A SPECIFIC LIST NUMBER, BUT REPORTED THE EVENT WAS WITH EITHER LIST #16021 OR LIST #16107. THE TWO LIST NUMBERS HAVE A COMMON DEVICE NAME OF 80FRN AND HAVE A 510K OF K041550. 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 TUBING SET INTO THE PRIMARY SOLUTION CONTAINER. THE SYMBIQ PRIMARY TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED SOLUTION. THE SECONDARY TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF MAGNESIUM. THE HEIGHT OF THE SECONDARY SOLUTION CONTAINER IN RELATION TO THE PRIMARY SOLUTION CONTAINER WAS REPORTED TO BE "CONNECTED APPROPRIATELY." IT WAS REPORTED THAT PRIOR TO THE DELIVERIES BEING INITIATED WHILE THE NURSE WAS PROGRAMMING THE PUMP, THE NURSE NOTED THAT THE SECONDARY SOLUTION WAS BACKFLOWING INTO THE PRIMARY SOLUTION CONTAINER. THE NURSE INITIALLY REPLACED THE SECONDARY TUBING SET; HOWEVER, BACKFLOW WAS NOTED. THE NURSE THEN REPLACED THE PRIMARY TUBING SET AND NO BACKFLOW WAS NOTED. THE THERAPIES WERE INITIATED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO DELAY IN THERAPY CRITICAL FOR THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. 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 5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LIST # 12667, LOT # UNK| SECONDARY TUBING SET